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A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)

Primary Purpose

Non-alcoholic Steatohepatitis (NASH)

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 456906
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Steatohepatitis (NASH)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • North Alabama Health Research, LLC
  • Southern California Research Center
  • Velocity Clinical Research
  • Velocity Clinical Research
  • Quest Clinical Research
  • Peak Gastroenterology Associates
  • Integrity Clinical Research, LLC
  • Covenant Metabolic Specialists, LLC
  • Optimus U Corporation
  • Sanchez Clinical Research ,Inc
  • Ocala GI Research
  • Omega Research Orlando, LLC
  • Covenant Metabolic Specialists, LLC
  • Gastrointestinal Specialists of Georgia
  • Digestive Research Alliance of Michiana
  • University of Iowa Hospitals and Clinics
  • Delta Research Partners, LLC
  • Centex Studies, Inc.
  • Tandem Clinical Research
  • NECCR PrimaCare Research, LLC
  • National Diabetes and Obesity Research Institute
  • Gastrointestinal Associates
  • AIG Digestive Disease Research
  • Northeast GI Research Division
  • Lucas Research, Inc.
  • Digestive Diseases Research Center
  • Palmetto Clinical Research
  • Digestive Health Research, LLC
  • Texas Clinical Research Institute, LLC
  • Texas Liver Institute
  • South Texas Research Institute
  • South Texas Research Institute
  • Houston Methodist Hospital
  • American Research Corporation at the Texas Liver Institute
  • Pinnacle Clinical Research
  • Virginia Commonwealth University
  • Gold Coast University Hospital
  • Monash Medical Centre
  • Royal Melbourne Hospital
  • Medical University of Graz State Hospital - University Hospital Graz
  • Medical University of Innsbruck
  • Ordensklinikum Linz GmbH - Barmherzige Schwestern
  • Edegem - UNIV UZ Antwerpen
  • University Hospital (LHSC)
  • Toronto Liver Centre
  • Ecogene-21
  • Beijing Ditan Hospital Capital Medical University
  • Beijing Tsinghua Changgung Hospital
  • Peking University People's Hospital
  • Beijing Friendship Hospital
  • The First Hospital of Jilin University
  • The First Afiliated Hospital, Sun Yet-sen University
  • NanFang Hosptial
  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
  • First People's hospital of Yunann Province
  • The Second Hospital of Nanjing
  • Shanghai Public Health Clinical Center
  • Tianjin Third Central Hospital
  • The First Affiliated Hospital of Wenzhou Med College
  • Regional Hospital Liberec
  • General Faculty Hospital, Prague
  • HOP l'Archet
  • HOP La Pitié Salpêtrière
  • HOP Haut-Lévêque
  • HOP Civil
  • Universitätsklinikum Aachen, AöR
  • Synexus Clinical Research GmbH
  • Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
  • Universitätsklinikum Düsseldorf
  • Synexus Clinical Research GmbH
  • Synexus Clinical Research GmbH
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Universitätsklinikum Mannheim GmbH
  • Universitätsklinikum Ulm
  • Attikon University Hospital
  • General Hospital of Thessaloniki "Hippokrateio"
  • Prince of Wales Hospital
  • Queen Mary Hospital
  • Synexus Hungary Healthcare Service Ltd.
  • Fed.St. Istvan&Szent Laszlo Hospital
  • Synexus Hungary Healthcare Service Ltd
  • Shaare Zedek Medical Center, Jerusalem 91031
  • Western Galilee Hospital
  • Rabin Medical Center Beilinson
  • Sourasky Medical Center
  • The Chaim Sheba Medical Center
  • Ospedale Civile di Baggiovara
  • A.O. Univ. Policlinico "Paolo Giaccone"
  • Poli Univ A. Gemelli
  • Istituto Clinico Humanitas
  • IRCCS Ospedale "Casa Sollievo della Sofferenza"
  • AO Città della Salute e Scienza
  • Ehime University Hospital
  • Fukuiken Saiseikai Hospital
  • Kurume University Hospital
  • Ogaki Municipal Hospital
  • Japan Community Health Care Organization Hokkaido Hospital
  • Kagawa University Hospital
  • Kagawa Prefectural Central Hospital
  • St. Marianna University Hospital
  • Kitasato University Hospital
  • Yokohama City University Hospital
  • National Hospital Organization Yokohama Medical Center
  • Kumamoto University Hospital
  • University Hospital Kyoto Prefectural University of Medicine
  • Shinshu University Hospital
  • Nagano Municipal Hospital
  • Nara Medical University Hospital
  • Suita Hospital
  • Saga University Hospital
  • Hamamatsu University Hospital
  • Juntendo University Shizuoka Hospital
  • Tokyo Medical and Dental University Hospital
  • Pusan National Univ. Hosp
  • Keimyung University Dongsan Hospital
  • Seoul National University Hospital
  • Universiti Sains Malaysia Hospital
  • University of Malaya Medical Centre
  • Hospital Selayang
  • Amsterdam UMC, Locatie AMC
  • Leids Universitair Medisch Centrum (LUMC)
  • Sint Franciscus, Locatie Vlietland
  • New Zealand Clinical Research (NZCR)
  • Middlemore Clinical Trials
  • INTERCORE Medical Center
  • Synexus Poland, Branch in Czestochowa
  • Private health care facility "Your Health EL" LLC
  • Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk
  • Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia
  • University Clinical Center Professor Gibinskiego
  • University Hospital in Krakow
  • Medicome Limited Liability Company
  • Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa
  • Synexus Poland, Branch in Wroclaw
  • ETG Zamosc
  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
  • Centro Hospitalar Universitário São João,EPE
  • National University Hospital
  • Singapore General Hospital
  • Hospital Vall d'Hebron
  • Hospital Puerta de Hierro
  • Hospital de Montecelo
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Virgen del Rocío
  • Hospital General Universitario de Valencia
  • Chia Yi Christian Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • National Chen Kung University, Dept of Neurology
  • Chang Gung Memorial Hospital(Linkou)
  • Queen Elizabeth Hospital
  • Synexus - Hexham
  • Aintree University Hospital
  • King's College Hospital
  • Queen's Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BI 456906 low dose

BI 456906 medium dose

BI 456906 high dose

Placebo

Arm Description

low dose

medium dose

high dose

Placebo

Outcomes

Primary Outcome Measures

Percentage of patients with histological improvement of NASH (NAS reduction of 2 or more points) after 48 weeks of treatment
Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) represents the sum of scores for steatosis (0-3), lobular inflammation (0-3) and ballooning (0-2); the total score ranges from 0 to 8. Improvement in histological findings is defined as a composite of: Improvement in NASH is defined as a composite of: Decrease of at least 2 points in NAS with at least 1 point decrease in NAS subscore of either lobular inflammation or ballooning AND No worsening of fibrosis, defined as absence of any increase in the fibrosis stage.

Secondary Outcome Measures

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
Assessment will be done by magnetic resonance imaging proton density fat fraction measurement (MRI-PDFF)
Absolute and relative change of liver fat content from baseline after 48 weeks of treatment assessed by MRI-PDFF
Improvement of fibrosis (yes/no) defined as at least one stage decrease in fibrosis stage after 48 weeks of treatment assessed by liver biopsy
Absolute change from baseline in NAS after 48 weeks of treatment assessed by liver biopsy

Full Information

First Posted
February 24, 2021
Last Updated
October 16, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT04771273
Brief Title
A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
November 22, 2023 (Anticipated)
Study Completion Date
December 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly, which means by chance. There are 3 groups that each receive a different dose of BI 456906 and there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injection looks like the BI 456906 injection but does not contain any medicine. Participants are in the study for a little over 1 year (60 weeks). During this time, they visit the study site several times and have some video calls in addition. At the visits, the study doctors take different measurements. To see whether the treatment works, the doctors take a very small sample of liver tissue (biopsy) from each participant at the start and at the end of the study. They also examine the liver by ultrasound and MRI. The doctors also regularly check the general health of the participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Steatohepatitis (NASH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
295 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 456906 low dose
Arm Type
Experimental
Arm Description
low dose
Arm Title
BI 456906 medium dose
Arm Type
Experimental
Arm Description
medium dose
Arm Title
BI 456906 high dose
Arm Type
Experimental
Arm Description
high dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
BI 456906
Intervention Description
BI 456906
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percentage of patients with histological improvement of NASH (NAS reduction of 2 or more points) after 48 weeks of treatment
Description
Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) represents the sum of scores for steatosis (0-3), lobular inflammation (0-3) and ballooning (0-2); the total score ranges from 0 to 8. Improvement in histological findings is defined as a composite of: Improvement in NASH is defined as a composite of: Decrease of at least 2 points in NAS with at least 1 point decrease in NAS subscore of either lobular inflammation or ballooning AND No worsening of fibrosis, defined as absence of any increase in the fibrosis stage.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
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
Description
Assessment will be done by magnetic resonance imaging proton density fat fraction measurement (MRI-PDFF)
Time Frame
Week 48
Title
Absolute and relative change of liver fat content from baseline after 48 weeks of treatment assessed by MRI-PDFF
Time Frame
Week 48
Title
Improvement of fibrosis (yes/no) defined as at least one stage decrease in fibrosis stage after 48 weeks of treatment assessed by liver biopsy
Time Frame
Week 48
Title
Absolute change from baseline in NAS after 48 weeks of treatment assessed by liver biopsy
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. 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. Patients willing and able to undergo liver biopsies per protocol as judged by the Investigator. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 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. Exclusion Criteria: 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. 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. 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. 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. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at Visit 1. 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. 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.
Facility Information:
Facility Name
North Alabama Health Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Velocity Clinical Research
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Velocity Clinical Research
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Integrity Clinical Research, LLC
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Covenant Metabolic Specialists, LLC
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Optimus U Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Sanchez Clinical Research ,Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Ocala GI Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Omega Research Orlando, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Covenant Metabolic Specialists, LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Digestive Research Alliance of Michiana
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46635
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Delta Research Partners, LLC
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
Country
United States
Facility Name
Centex Studies, Inc.
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
NECCR PrimaCare Research, LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
National Diabetes and Obesity Research Institute
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39532
Country
United States
Facility Name
Gastrointestinal Associates
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
AIG Digestive Disease Research
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
Northeast GI Research Division
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28027
Country
United States
Facility Name
Lucas Research, Inc.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Digestive Diseases Research Center
City
Greenwood
State/Province
South Carolina
ZIP/Postal Code
29646
Country
United States
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Digestive Health Research, LLC
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Texas Clinical Research Institute, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Texas Liver Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
South Texas Research Institute
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78520
Country
United States
Facility Name
South Texas Research Institute
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
American Research Corporation at the Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Medical University of Graz State Hospital - University Hospital Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medical University of Innsbruck
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Ordensklinikum Linz GmbH - Barmherzige Schwestern
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
Edegem - UNIV UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
University Hospital (LHSC)
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Ecogene-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Beijing Ditan Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Friendship Hospital
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
The First Afiliated Hospital, Sun Yet-sen University
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
NanFang Hosptial
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
First People's hospital of Yunann Province
City
Kunming
ZIP/Postal Code
650032
Country
China
Facility Name
The Second Hospital of Nanjing
City
Nanjing
ZIP/Postal Code
210003
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
ZIP/Postal Code
201508
Country
China
Facility Name
Tianjin Third Central Hospital
City
Tianjin
ZIP/Postal Code
300170
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Med College
City
Wenxzhou
ZIP/Postal Code
325000
Country
China
Facility Name
Regional Hospital Liberec
City
Liberec
ZIP/Postal Code
460 63
Country
Czechia
Facility Name
General Faculty Hospital, Prague
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
HOP l'Archet
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
HOP La Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
HOP Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
HOP Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Universitätsklinikum Aachen, AöR
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Frankfurt
ZIP/Postal Code
60313
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Mannheim GmbH
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Attikon University Hospital
City
Haidari-Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
General Hospital of Thessaloniki "Hippokrateio"
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Prince of Wales Hospital
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Synexus Hungary Healthcare Service Ltd.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Fed.St. Istvan&Szent Laszlo Hospital
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Synexus Hungary Healthcare Service Ltd
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Shaare Zedek Medical Center, Jerusalem 91031
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Western Galilee Hospital
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Rabin Medical Center Beilinson
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Ospedale Civile di Baggiovara
City
Baggiovara (MO)
ZIP/Postal Code
41126
Country
Italy
Facility Name
A.O. Univ. Policlinico "Paolo Giaccone"
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Poli Univ A. Gemelli
City
Roma
ZIP/Postal Code
00195
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
ZIP/Postal Code
20089
Country
Italy
Facility Name
IRCCS Ospedale "Casa Sollievo della Sofferenza"
City
SAN Giovanni Rotondo (FG)
ZIP/Postal Code
71013
Country
Italy
Facility Name
AO Città della Salute e Scienza
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ehime University Hospital
City
Ehime, Toon
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Fukuiken Saiseikai Hospital
City
Fukui, Fukui
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
Kurume University Hospital
City
Fukuoka, Kurume
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Gifu, Ogaki
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Japan Community Health Care Organization Hokkaido Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
062-8618
Country
Japan
Facility Name
Kagawa University Hospital
City
Kagawa, Kita-gun
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Kagawa, Takamatsu
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
St. Marianna University Hospital
City
Kanagawa, Kawasaki
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kitasato University Hospital
City
Kanagawa, Sagamihara
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Yokohama City University Hospital
City
Kanagawa, Yokohama
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
National Hospital Organization Yokohama Medical Center
City
Kanagawa, Yokohama
ZIP/Postal Code
245-8575
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto, Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto, Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Shinshu University Hospital
City
Nagano, Matsumoto
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Nagano Municipal Hospital
City
Nagano, Nagano
ZIP/Postal Code
381-8551
Country
Japan
Facility Name
Nara Medical University Hospital
City
Nara, Kashihara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Suita Hospital
City
Osaka, Suita
ZIP/Postal Code
564-0013
Country
Japan
Facility Name
Saga University Hospital
City
Saga, Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Shizuoka, Hamamatsu
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Juntendo University Shizuoka Hospital
City
Shizuoka, Izunokuni
ZIP/Postal Code
410-2295
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Tokyo, Bunkyo-ku
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Pusan National Univ. Hosp
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Universiti Sains Malaysia Hospital
City
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Selayang
City
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Amsterdam UMC, Locatie AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum (LUMC)
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Sint Franciscus, Locatie Vlietland
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
New Zealand Clinical Research (NZCR)
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Middlemore Clinical Trials
City
Papatoetoe
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
INTERCORE Medical Center
City
Bydgoszcz
ZIP/Postal Code
85-605
Country
Poland
Facility Name
Synexus Poland, Branch in Czestochowa
City
Czestochowa
ZIP/Postal Code
42202
Country
Poland
Facility Name
Private health care facility "Your Health EL" LLC
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk
City
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
Facility Name
University Clinical Center Professor Gibinskiego
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
University Hospital in Krakow
City
Krakow
ZIP/Postal Code
30688
Country
Poland
Facility Name
Medicome Limited Liability Company
City
Oswiecim
ZIP/Postal Code
32600
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Synexus Poland, Branch in Wroclaw
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
ETG Zamosc
City
Zamosc
ZIP/Postal Code
22400
Country
Poland
Facility Name
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar Universitário São João,EPE
City
Porto
ZIP/Postal Code
4202-451
Country
Portugal
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
168753
Country
Singapore
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital de Montecelo
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Chia Yi Christian Hospital
City
ChiaYi
ZIP/Postal Code
60002
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
National Chen Kung University, Dept of Neurology
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital(Linkou)
City
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Synexus - Hexham
City
Hexham
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
ZIP/Postal Code
NG7 2RD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info

Learn more about this trial

A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)

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