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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06200207
Registration number
NCT06200207
Ethics application status
Date submitted
28/12/2023
Date registered
10/01/2024
Date last updated
3/06/2024
Titles & IDs
Public title
A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation
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Scientific title
Effects of Ziltivekimab Versus Placebo on Heart Failure Symptoms and Physical Function in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
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Secondary ID [1]
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U1111-1293-7516
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Secondary ID [2]
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NN6018-4914
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Universal Trial Number (UTN)
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Trial acronym
ATHENA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ziltivekimab
Treatment: Drugs - Placebo
Active Comparator: Ziltivekimab - Participants will receive ziltivekimab administered subcutaneously (s.c.) once-monthly and added to standard of care for 12 months.
Placebo Comparator: Placebo - Participants will receive placebo matched to ziltivekimab administered s.c. once-monthly and added to standard of care for 12 months.
Treatment: Drugs: Ziltivekimab
Zilitivekimab will be administered subcutaneously once-monthly.
Treatment: Drugs: Placebo
Placebo matched to ziltivekimab will be administered subcutaneously once-monthly.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
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Assessment method [1]
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Measured as score (score on scale; range; 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
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Timepoint [1]
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From randomisation (month 0) to end-of-treatment (month 12)
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Secondary outcome [1]
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Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no)
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Assessment method [1]
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Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
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Timepoint [1]
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From randomisation (month 0) to end-of-treatment (month 12)
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Secondary outcome [2]
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Participant achieving threshold for clinically meaningful within-participant change in 6-minute walk distance (6MWD) (yes/no)
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Assessment method [2]
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Measured as count of participants.
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Timepoint [2]
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From randomisation (month 0) to end-of-treatment (month 12)
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Secondary outcome [3]
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Participants improving 5 points or more in KCCQ-CSS (yes/no)
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Assessment method [3]
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0
Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
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Timepoint [3]
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From randomisation (month 0) to end-of-treatment (month 12)
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Secondary outcome [4]
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Participants improving 10 points or more in KCCQ-CSS (yes/no)
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Assessment method [4]
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Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
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Timepoint [4]
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From randomisation (month 0) to end-of-treatment (month 12)
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Secondary outcome [5]
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Change in subscales of KCCQ (total symptom score, physical limitations score, social limitations score, and health-related quality of life)
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Assessment method [5]
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Measured as score (score on scale; range 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
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Timepoint [5]
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From randomisation (month 0) to end-of-treatment (month 12)
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Secondary outcome [6]
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Change in six-minute walk distance (6MWD)
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Assessment method [6]
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Measured in meters.
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Timepoint [6]
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From randomisation (month 0) to end-of-treatment (month 12)
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Secondary outcome [7]
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Change in high-sensitivity C-reactive protein (hs-CRP)
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Assessment method [7]
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Measured as ratio to baseline.
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Timepoint [7]
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From randomisation (month 0) to end-of-treatment (month 12)
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Secondary outcome [8]
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Participants experiencing improvement in New York heart association (NYHA) Class (yes/no)
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Assessment method [8]
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Measured as count of participants. The New York Heart Association (NYHA) classification provides a simple way of classifying the extent of heart failure (HF). It classifies patients in one of four categories based on their limitations during physical activity - Class I: Participant with cardiac disease but without resulting limitations of physical activity, Class II: Participants with cardiac disease resulting in slight limitation of physical activity, Class III: Participants with cardiac disease resulting in marked limitation of physical activity, Class IV: Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort.
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Timepoint [8]
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From randomisation (month 0) to end-of-treatment (month 12)
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Secondary outcome [9]
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Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP)
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Assessment method [9]
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Measured as ratio to baseline.
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Timepoint [9]
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From randomisation (month 0) to end-of-treatment (month 12)
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Secondary outcome [10]
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Change in eGFR (CKD-EPI)
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Assessment method [10]
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eGFR (CKD-EPI) is estimated glomerular filtration rate chronic kidney disease - epidemiology collaboration. Measured in milliliter per minute per 1.73 square meter (ml/min/1.73^2).
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Timepoint [10]
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From randomisation (month 0) to end-of-treatment (month 12)
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Eligibility
Key inclusion criteria
- Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2
milligrams per liter (mg/L) at screening (visit 1)
- Disease specific - cardiovascular:
- N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than or equal to 225
picograms per milliliter (pg/mL) (375 pg/mL for participants with atrial
fibrillation/flutter) at screening
- Diagnosis of heart failure (New York heart association (NYHA) Class II-III)
- Left ventricular ejection fraction (LVEF) greater than 40 percent documented by
echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be
documented in medical records and the most recent measurement must be used to
determine eligibility with no interim event signalling potential deterioration in
ejection fraction (example myocardial infarction (MI) or heart failure (HF)
hospitalisation)
- Structural heart disease and/or functional heart disease documented by
echocardiography within 12 months prior to or at screening (visit 1) showing at least
one of the following:
1. Left atrial (LA) volume index greater than 34 milliliter per square meter
(mL/m^2)
2. LA diameter greater than or equal to 3.8 centimeter (cm)
3. LA length greater than or equal to 5.0 cm
4. LA area greater than or equal to 20 square centimeter (cm^2)
5. LA volume greater than or equal to 55 milliliter (mL)
6. Intraventricular septal thickness greater than or equal to 1.1 cm
7. Posterior wall thickness greater than or equal to 1.1 cm
8. LV mass index greater than or equal to 115 gram per square meter (g/m^2) in men
or greater than or equal to 95 g/m^2 in women
h) E/e' (mean septal and lateral) greater than or equal to 10 i) e' (mean septal and
lateral) less than 9 centimeter per second (cm/s)
- No heart failure hospitalisations or urgent heart failure visits between screening and
randomisation
- Able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of
100 metres
- Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score lesser than 80
at screening
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Medical conditions - cardiovascular:
- Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack,
or heart failure hospitalisation within 30 days prior to screening (visit 1)
- Systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) at
screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient
should be receiving greater than or equal to 3 antihypertensive drugs
- Heart rate above 110 or below 40 beats per minute as evaluated on the
Electrocardiogram (ECG) performed at screening (visit 1)
- Planned coronary, carotid or peripheral artery revascularisation known during the
screening period (visit 1)
- Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known
during the screening period (visit 1)
- Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure
(thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit
2) or any major surgical procedure planned at the time of randomisation (visit 2)
- Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid),
arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic
hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis,
constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary
valve disease
- Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease
including chronic obstructive pulmonary disease (COPD)
- Any other condition judged by the investigator that could account for heart failure
symptoms and signs (e.g., anaemia, hypothyroidism)
- Medical conditions - infections/immunosuppression:
- Clinical evidence of, or suspicion of, active infection at the discretion of the
investigator
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
17/08/2026
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Actual
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Sample size
Target
680
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [2]
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Illawarra Heart Health Centre - Wollongong
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Recruitment hospital [3]
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The Prince Charles Hospital - Brisbane
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Recruitment hospital [4]
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Ballarat Base Hospital - Ballarat
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Recruitment hospital [5]
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The Cardiologists Pty Ltd - Epping
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Recruitment hospital [6]
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Fiona Stanley Hospital Cardiology - Murdoch
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Recruitment postcode(s) [1]
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2305 - New Lambton Heights
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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4032 - Brisbane
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Recruitment postcode(s) [4]
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3350 - Ballarat
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Recruitment postcode(s) [5]
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3076 - Epping
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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
0
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United States of America
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State/province [2]
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Arkansas
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Country [3]
0
0
United States of America
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State/province [3]
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California
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Country [4]
0
0
United States of America
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State/province [4]
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Florida
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Country [5]
0
0
United States of America
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State/province [5]
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Georgia
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Country [6]
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United States of America
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State/province [6]
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Illinois
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Country [7]
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United States of America
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State/province [7]
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Kentucky
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United States of America
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Maryland
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United States of America
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State/province [9]
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Michigan
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United States of America
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Missouri
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United States of America
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Nevada
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Morón
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Argentina
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Salta
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Argentina
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San Miguel De Tucumán, Tucumán.
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Bulgaria
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Haskovo
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Sofia
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Alberta
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Ontario
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Brno
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Praha 7
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Svitavy
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Czechia
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Trutnov
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France
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Chambray Les Tours
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France
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Poitiers
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France
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Rennes
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France
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Rouen cedex
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France
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Toulon
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France
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State/province [38]
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Vandoeuvre Les Nancy
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Germany
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Dresden
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Germany
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Elsterwerda
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Frankfurt
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Germany
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Freiburg
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Attiki
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Athens
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Greece
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Chaidari, Athens
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Greece
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Chios
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Greece
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Larissa
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Greece
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Marousi
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Greece
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Thessaloniki
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Andhra Pradesh
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India
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Andra Pradesh
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India
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Delhi
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India
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Gujarat
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India
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Karnataka
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Maharashtra
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Odisha
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Rajasthan
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India
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Telangana
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India
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Uttar Pradesh
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India
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West Bengal
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India
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Puducherry
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Malaysia
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Johor
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Malaysia
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Kedah
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Malaysia
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Pahang
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Perak
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Malaysia
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Wilayah Persekutuan Kuala Lumpur
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Kajang
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Malaysia
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Kota Bharu, Kelantan
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Poland
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Dolnoslaskie
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Kujawsko-Pomorskie
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Lodzkie
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Lubelskie
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Malopolskie
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Podlaskie
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Pomorskie
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Bydgoszcz
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Gdynia
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Poznan
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Poland
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Warszawa
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Portugal
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Guilhufe - Penafiel
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Portugal
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Lisboa
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Portugal
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State/province [84]
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Lisbon
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Country [85]
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Portugal
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State/province [85]
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Setubal
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Country [86]
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Spain
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State/province [86]
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Castilla Y León
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Country [87]
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Spain
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State/province [87]
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Madrid
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Country [88]
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Spain
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State/province [88]
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Sanlúcar de Barrameda
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Country [89]
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Spain
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State/province [89]
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Santiago de Compostela
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Country [90]
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Spain
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State/province [90]
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Sevilla
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Country [91]
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Spain
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State/province [91]
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Valencia
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Country [92]
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Turkey
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State/province [92]
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Adana
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Country [93]
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Turkey
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State/province [93]
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Afyon
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Country [94]
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Turkey
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State/province [94]
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Ankara
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Country [95]
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Turkey
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State/province [95]
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Bursa
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Country [96]
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Turkey
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State/province [96]
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Edirne
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Country [97]
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Turkey
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State/province [97]
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Istanbul
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Country [98]
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Turkey
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State/province [98]
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Kayseri
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Country [99]
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Turkey
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State/province [99]
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Kocaeli
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Country [100]
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United Kingdom
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State/province [100]
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Highland
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Country [101]
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United Kingdom
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State/province [101]
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Dundee
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Country [102]
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United Kingdom
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State/province [102]
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Peterborough
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Country [103]
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United Kingdom
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State/province [103]
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West Sussex
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novo Nordisk A/S
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06200207
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Transparency dept. 2834
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Address
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Novo Nordisk A/S
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Novo Nordisk
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Address
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0
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0
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Phone
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(+1) 866-867-7178
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Fax
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0
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT06200207
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