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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05171075




Registration number
NCT05171075
Ethics application status
Date submitted
22/11/2021
Date registered
28/12/2021

Titles & IDs
Public title
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
Scientific title
A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab vs. Dalteparin on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With GI/GU Associated VTE
Secondary ID [1] 0 0
2021-003085-12
Secondary ID [2] 0 0
ANT-008
Universal Trial Number (UTN)
Trial acronym
MAGNOLIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Deep Venous Thrombosis 0 0
Pulmonary Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Abelacimab
Treatment: Drugs - Dalteparin

Experimental: Abelacimab - Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously

Active comparator: Dalteparin - Dalteparin administered subcutaneously daily


Treatment: Other: Abelacimab
Abelacimab 150 mg

Treatment: Drugs: Dalteparin
Dalteparin 200 IU/kg/day followed by 150 IU/kg/day
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first event of centrally adjudicated VTE recurrence consisting of new proximal deep venous thrombosis, new pulmonary embolism (PE) or fatal PE, including unexplained death for which PE cannot be ruled out
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Time to first event of ISTH-adjudicated major or clinically relevant non-major (CRNM) bleeding events
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Net clinical benefit defined as survival without VTE recurrence, or major or CRNM bleeding
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
* Male or female subjects =18 years old or other legal maturity age according to the country of residence
* Confirmed GI (colorectal, pancreatic, gastric, esophageal, gastro-esophageal junction or hepatobiliary) or confirmed GU (renal, ureteral, bladder, prostate, or urethra) cancers if:

* Unresectable, locally advanced, metastatic, or non-metastatic GI/GU cancer and
* No intended curative surgery during the study
* Confirmed symptomatic or incidental proximal lower limb deep vein thrombosis (DVT) (i.e., popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a confirmed symptomatic pulmonary embolism (PE), or an incidental PE in a segmental, or larger pulmonary artery. Patients are eligible within 120 hours from diagnosis of the qualifying VTE.
* Anticoagulation therapy with LMWH for at least 6 months is indicated
* Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) occurrence of DVT and/or PE
* More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, or other anticoagulants
* An indication to continue treatment with therapeutic doses of an anticoagulant other than for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanical heart valve, prior VTE)
* PE leading to hemodynamic instability (systolic BP <90 mmHg or shock).
* Acute ischemic or hemorrhagic stroke or intracranial hemorrhage, in the last 4 weeks preceding screening.
* Brain trauma, or cerebral or a spinal cord surgery or spinal procedures such as lumbar puncture or epidural/spinal anesthesia within 4 weeks of screening
* Need for aspirin in a dosage of more than 100 mg/day or, any other antiplatelet agent alone or in combination with aspirin
* Bleeding requiring medical attention at the time of randomization or in the preceding 4 weeks
* Planned brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization
* History of heparin induced thrombocytopenia
* Infective acute or subacute endocarditis at the time of presentation
* Primary brain cancer or untreated intracranial metastasis
* Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at screening
* Life expectancy of <3 months at randomization
* Calculated creatinine clearance (CrCl) <30 mL/min at the screening visit
* Platelet count <50,000/ mm3 at the screening visit
* Hemoglobin <8 g/dL at the screening visit
* Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase =3 times and/or bilirubin =2 times the upper limit of normal (ULN) at the screening visit in the absence of clinical explanation
* Uncontrolled hypertension (systolic blood pressure [BP] > 180 mm Hg or diastolic BP >100 mm Hg despite antihypertensive treatment)
* Women of child-bearing potential (WOCBP) who are unwilling or unable to use highly effective contraceptive measures during the study from screening up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab
* Sexually active males with sexual partners of childbearing potential must agree to use a condom or other reliable contraceptive measure up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab
* Pregnant or breast-feeding women
* History of hypersensitivity to any of the study drugs (including dalteparin) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for dalteparin
* Subjects with any condition that in the judgement of the Investigator would place the subject at increased risk of harm if he/she participated in the study
* Use of other investigational (not-registered) drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. Participation in academic non-interventional studies or interventional studies, comprising testing different strategies or different combinations of registered drugs is permitted.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
1020
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Northern Health - Epping
Recruitment hospital [5] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [6] 0 0
Perth Blood Institute - Perth
Recruitment hospital [7] 0 0
The Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3076 - Epping
Recruitment postcode(s) [5] 0 0
2139 - Concord
Recruitment postcode(s) [6] 0 0
6005 - Perth
Recruitment postcode(s) [7] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Massachusetts
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United States of America
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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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New Jersey
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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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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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Texas
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Austria
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Graz
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Austria
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Neustadt
Country [17] 0 0
Austria
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Vienna
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Canada
State/province [18] 0 0
Ontario
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Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Canada
State/province [20] 0 0
Calgary
Country [21] 0 0
Canada
State/province [21] 0 0
Marie
Country [22] 0 0
Canada
State/province [22] 0 0
Toronto
Country [23] 0 0
China
State/province [23] 0 0
Beijing
Country [24] 0 0
China
State/province [24] 0 0
Ch'ang-ch'un
Country [25] 0 0
China
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Guangdong
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China
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Guangzhou
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China
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Huizhou
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China
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Nanjing
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China
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Tongzhou
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China
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Wenzhou
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China
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Wuhan
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China
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Zhejiang
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Czechia
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Brno
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Czechia
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Hradec Králové
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Czechia
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Nová Ves Pod Pleší
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Czechia
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Prague
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Czechia
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Praha
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France
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Cedex
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France
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Chantemesse
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France
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Renouiflers
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France
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Rue Du Morvan
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France
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Amiens
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France
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Angers
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France
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Clermont-Ferrand
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France
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Dijon
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France
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Grenoble
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France
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Limoges
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France
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Marseille
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France
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Paris
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France
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Pierre-Bénite
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France
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Rouen
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France
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Saint-Étienne
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France
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Strasbourg
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France
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Toulon
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France
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Vandœuvre-lès-Nancy
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Germany
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Dresden
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Germany
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Görlitz
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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Leipzig
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Eger
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Hungary
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Kecskemét
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Hungary
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Pécs
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Ireland
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Cork
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Ireland
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Dublin
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Ireland
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Limerick
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Italy
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Bari
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Castelfranco Veneto
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Italy
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Chieti
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Italy
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Cosenza
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Italy
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Faenza
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Italy
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Genova
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Italy
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Grosseto
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Italy
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Milano
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Italy
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Modena
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Italy
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Napoli
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Italy
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Padova
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Italy
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Parma
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Italy
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Perugia
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Italy
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Pisa
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Italy
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Reggio Emilia
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Italy
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Roma
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Italy
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Rozzano
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Italy
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Treviso
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Italy
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Udine
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Italy
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Varese
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Italy
State/province [91] 0 0
Venezia
Country [92] 0 0
Italy
State/province [92] 0 0
Verduno
Country [93] 0 0
Italy
State/province [93] 0 0
Vicenza
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Korea, Republic of
State/province [94] 0 0
Anyang-Si
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Korea, Republic of
State/province [95] 0 0
Bucheon
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Korea, Republic of
State/province [96] 0 0
Busan
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Korea, Republic of
State/province [97] 0 0
Daegu
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
State/province [99] 0 0
Jeonju
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Korea, Republic of
State/province [100] 0 0
Pusan
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Korea, Republic of
State/province [101] 0 0
Seongnam
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Korea, Republic of
State/province [102] 0 0
Seoul
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Latvia
State/province [103] 0 0
Daugavpils
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Latvia
State/province [104] 0 0
Liepaja
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Latvia
State/province [105] 0 0
Riga
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Netherlands
State/province [106] 0 0
Amersfoort
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Netherlands
State/province [107] 0 0
Amsterdam
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Netherlands
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Beverwijk
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Netherlands
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Den Haag
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Netherlands
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Dordrecht
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Netherlands
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Groningen
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Netherlands
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Haarlem
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Netherlands
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Hilversum
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Netherlands
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Holland
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Netherlands
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Leiden
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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Norway
State/province [118] 0 0
Fredrikstad
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Norway
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Lørenskog
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Norway
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Oslo
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Spain
State/province [121] 0 0
Alicante
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Elche
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Spain
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Granada
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Spain
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Jaén
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Spain
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Lugo
Country [128] 0 0
Spain
State/province [128] 0 0
Madrid
Country [129] 0 0
Spain
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Majadahonda
Country [130] 0 0
Spain
State/province [130] 0 0
Ourense
Country [131] 0 0
Spain
State/province [131] 0 0
Oviedo
Country [132] 0 0
Spain
State/province [132] 0 0
Pamplona
Country [133] 0 0
Spain
State/province [133] 0 0
Sabadell
Country [134] 0 0
Spain
State/province [134] 0 0
Santander
Country [135] 0 0
Spain
State/province [135] 0 0
Santiago De Compostela
Country [136] 0 0
Spain
State/province [136] 0 0
Sevilla
Country [137] 0 0
Sweden
State/province [137] 0 0
Sundsvall
Country [138] 0 0
Switzerland
State/province [138] 0 0
Geneve
Country [139] 0 0
Switzerland
State/province [139] 0 0
Zürich
Country [140] 0 0
Taiwan
State/province [140] 0 0
Kaohsiung
Country [141] 0 0
Taiwan
State/province [141] 0 0
New Taipei City
Country [142] 0 0
Taiwan
State/province [142] 0 0
Taichung
Country [143] 0 0
Taiwan
State/province [143] 0 0
Tainan
Country [144] 0 0
Taiwan
State/province [144] 0 0
Taipei
Country [145] 0 0
United Kingdom
State/province [145] 0 0
England
Country [146] 0 0
United Kingdom
State/province [146] 0 0
ENG
Country [147] 0 0
United Kingdom
State/province [147] 0 0
SCO

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Anthos Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Itreas
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nancy Widener
Address 0 0
Country 0 0
Phone 0 0
239-284-3741
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/study/NCT05171075