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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04771273




Registration number
NCT04771273
Ethics application status
Date submitted
24/02/2021
Date registered
25/02/2021

Titles & IDs
Public title
A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
Scientific title
Multicenter, Double-blind, Parallel-group, Randomized, 48 Weeks, Dose-ranging, Placebo-controlled Phase II Trial to Evaluate Efficacy, Safety and Tolerability of Multiple Subcutaneous (s.c.) Doses of BI 456906 in Patients With Non-alcoholic Steatohepatitis (NASH) and Fibrosis.
Secondary ID [1] 0 0
2020-002723-11
Secondary ID [2] 0 0
1404-0043
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic Steatohepatitis (NASH) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 456906
Treatment: Drugs - Placebo

Experimental: BI 456906 low dose - low dose

Experimental: BI 456906 medium dose - medium dose

Experimental: BI 456906 high dose - high dose

Placebo comparator: Placebo - Placebo


Treatment: Drugs: BI 456906
BI 456906

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients with histological improvement of NASH (NAS reduction of 2 or more points) after 48 weeks of treatment
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Improvement of liver fat content (yes/no) defined as at least 30 percent (%) relative reduction in liver fat content after 48 weeks of treatment compared to baseline
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Absolute and relative change of liver fat content from baseline after 48 weeks of treatment assessed by MRI-PDFF
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Improvement of fibrosis (yes/no) defined as at least one stage decrease in fibrosis stage after 48 weeks of treatment assessed by liver biopsy
Timepoint [3] 0 0
Week 48
Secondary outcome [4] 0 0
Absolute change from baseline in NAS after 48 weeks of treatment assessed by liver biopsy
Timepoint [4] 0 0
Week 48

Eligibility
Key inclusion criteria
1. Male or female patients = 18 years (or who are of legal age in countries where that is greater than 18 years) and = 80 years of age at time of consent.
2. Diagnosis of non-alcoholic steatohepatitis (NASH) (Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) = 4, with at least 1 point in inflammation and ballooning each) and fibrosis stage F1-F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 6 months prior to randomization and stable body weight defined as less than 5% self-reported change in body weight between the historical biopsy and randomization, if a historical biopsy is used.
3. Liver fat fraction = 8% measured by Magnetic Resonance Imaging (MRI)-Proton Density Fat Fraction (PDFF) and liver stiffness > 6.0 kPa measured by FibroScan® at Visit 1 (if biopsy is scheduled during the screening period MRI-PDFF and FibroScan® assessments have to be performed prior to the biopsy). However, the diagnosis of NASH and fibrosis at liver biopsy (including historical biopsy) is the primary assessment to establish patient eligibility.
4. Patients willing and able to undergo liver biopsies per protocol as judged by the Investigator.
5. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
6. Women of childbearing potential (WOCBP)1 must be willing and able to use two forms of effective contraception where at least one form is highly effective methods of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.

Further inclusion criteria apply.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current or history of significant alcohol consumption (defined as intake of > 210 g/ week in males and > 140 g/ week in females on average over a consecutive period of more than 3 months) or inability to reliably quantify alcohol consumption based on Investigator judgement within the last 5 years.
2. Intake of medications historically associated with liver injury, hepatic steatosis or steatohepatitis within 12 weeks prior to Visit 1. Intake of restricted medications or any medications considered likely to interfere with the safe conduct of the trial.
3. History of other forms of chronic liver disease (e.g., viral hepatitis, autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, Alpha-1 Antitrypsin (A1At) deficiency, history of liver transplantation). Hepatitis B and C testing will be done at Visit 1. Patients with positive Hepatitis B surface antigen (HBsAg) should be excluded. Patients treated for hepatitis C must have a negative RNA test at screening and also be Hepatitis C Virus (HCV) RNA negative for at least 3 years prior to screening in order to be eligible for the trial.
4. Suspicion, diagnosis, or history of hepatocellular carcinoma (HCC), or any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at Visit 1.
6. History of chronic or acute pancreatitis or elevation of serum lipase/amylase > 2x ULN or fasting serum triglyceride levels of > 500 mg/dL (> 5.65 mmol/L) at screening.
7. Known history of HIV (Human Immunodeficiency Virus) infection and/or tuberculosis and/or an acute COVID-19 infection at Visit 1 (confirmed by SARS CoV-2 RT-PCR test). Further exclusion criteria apply.

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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/12/2023
Sample size
Target
Accrual to date
Final
295
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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Colorado
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Florida
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Georgia
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Indiana
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Iowa
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Louisiana
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Massachusetts
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Mississippi
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New Jersey
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North Carolina
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South Carolina
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Tennessee
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Texas
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United States of America
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Virginia
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Belgium
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Edegem
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Changchun
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China
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Guangzhou
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China
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Hangzhou
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China
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Kunming
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China
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Nanjing
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China
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Shanghai
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China
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Tianjin
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China
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Wenxzhou
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Czechia
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Liberec
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Czechia
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Prague
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France
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Nice
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France
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Paris
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Pessac
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France
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Strasbourg
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Germany
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Aachen
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Berlin
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Bochum
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Düsseldorf
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Frankfurt
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Ulm
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Greece
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Haidari-Athens
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Greece
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Thessaloniki
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Gyula
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Israel
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Jerusalem
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Israel
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Nahariya
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Israel
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Tel-Hashomer
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Italy
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Baggiovara (MO)
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Italy
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Palermo
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Italy
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Roma
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Italy
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Rozzano (MI)
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Italy
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SAN Giovanni Rotondo (FG)
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Italy
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Torino
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Japan
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Ehime, Toon
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Fukui, Fukui
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Fukuoka, Kurume
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Gifu, Ogaki
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Hokkaido, Sapporo
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Kagawa, Kita-gun
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Kagawa, Takamatsu
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Kanagawa, Kawasaki
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Kanagawa, Sagamihara
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Kanagawa, Yokohama
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Kumamoto, Kumamoto
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Kyoto, Kyoto
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Nagano, Matsumoto
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Nagano, Nagano
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Nara, Kashihara
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Osaka, Suita
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Saga, Saga
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Shizuoka, Hamamatsu
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Shizuoka, Izunokuni
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Tokyo, Bunkyo-ku
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Seoul
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Malaysia
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Kelantan
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Malaysia
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Kuala Lumpur
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Malaysia
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Selangor
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Netherlands
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Amsterdam
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Leiden
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Auckland
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Papatoetoe
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Elblag
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Gdynia
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Katowice
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Krakow
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Oswiecim
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Warszawa
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Wroclaw
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Zamosc
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Portugal
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Lisboa
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Portugal
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Porto
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Majadahonda
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Spain
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Pontevedra
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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ChiaYi
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Taiwan
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Kaohsiung
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Taiwan
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Tainan
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Taiwan
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Taoyuan County
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Birmingham
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United Kingdom
State/province [119] 0 0
Hexham
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United Kingdom
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Liverpool
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United Kingdom
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London
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


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/NCT04771273