Phase
Condition
Hyponatremia
Hepatic Fibrosis
Treatment
BI 3802876
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria :
Male or female adults ≥18 to ≤75 years of age at the time of screening, and at least the legal age of consent in countries where it is > 18 years
Patients meeting criteria for Child-Pugh category A without history of previous decompensation event
Compensated Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis diagnosed by 1 of the following:
Biopsy (collected during screening or ≤ 5 years* prior to screening) showing cirrhosis (fibrosis stage 4) with steatosis or steatohepatitis.
Biopsy (collected during screening or ≤ 5 years* prior to screening) showing cryptogenic cirrhosis.
Biopsy showing steatosis or steatohepatitis prior to screening without confirmation of fibrosis stage 4, or current or previous imaging showing steatosis with no liver histology available must meet either one of the following inclusion criteria at screening:
Vibration-controlled transient elastography (VCTE) ≥ 15 kilopascals (kPa) plus 1 of the following, Magnetic Resonance Enterography (MRE) ≥4.2 kPa, platelet count <150,000/μL or imaging techniques (computed tomography (CT) scan and/or Magnetic Resonance Imaging (MRI) and/or Ultrasound) suggestive of cirrhosis.
VCTE measurement ≥ 20 kPa
Enhanced Liver Fibrosis (ELF) score ≥ 10.2 *If biopsy was collected > 365 days prior to screening either criteria a, b or c must be met Further inclusion criteria apply.
Exclusion Criteria :
Patients with clinically significant portal hypertension defined by any of the following:
VCTE ≥25 kPa if the platelets are ≥150,000/μL
VCTE ≥20 kPa if platelets are <150,000/μL
History of esophageal or gastric varices (Grade ≥1) on endoscopy
ELF score ≥11.3
Hepatic venous pressure gradient (HVPG) ≥10 mmHg
Other causes of liver disease based on medical history and/or centralized review of liver histology, including but not limited to alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis [PBC], primary sclerosing cholangitis [PSC], autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1- antitryspin deficiency
Chronic viral hepatitis parameters that would be considered exclusionary for the participation in this trial are (hepatitis B and C testing will be done at screening visit):
Hepatitis B virus (HBV): Past or present hepatitis B infection, including a positive hepatitis B surface antigen (HBsAg) and/or detectable HBV Deoxyribonucleic Acid (DNA).
Hepatitis C virus (HCV): Past or present hepatitis C infection, including positive hepatitis C antibodies and/or detectable HCV ribonucleic acid (RNA).
History of liver transplantation or patients listed for liver transplantation
Suspicion, confirmed diagnosis, or history of Hepatocellular Carcinoma (HCC)
Present or past evidence of decompensating events of liver cirrhosis
Model for End-Stage Liver Disease (MELD) score > 12, unless due to therapeutic anti-coagulation
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) within 1 year prior to screening
International Normalized Ratio (INR) >1.3 unless due to therapeutic anticoagulants or laboratory error Further exclusion criteria apply.
Study Design
Connect with a study center
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta T6G 2XB
CanadaSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35233
United StatesSite Not Available
Southern California Research Center
Coronado, California 92118
United StatesSite Not Available
Velocity Clinical Research, San Diego
La Mesa, California 91942
United StatesSite Not Available
Orange County Research Center
Lake Forest, California 92630
United StatesSite Not Available
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California 90027
United StatesSite Not Available
Pfleger Liver Institute
Los Angeles, California 90095
United StatesSite Not Available
Catalina Research Institute, LLC
Montclair, California 91763
United StatesSite Not Available
Velocity Clinical Research, San Diego
San Diego, California 91942
United StatesSite Not Available
Southern California Research Center
Coronado 5339663, California 5332921 92118
United StatesSite Not Available
Orange County Research Center
Lake Forest 5364514, California 5332921 92630
United StatesSite Not Available
Pfleger Liver Institute
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
Catalina Research Institute, LLC
Montclair 5374232, California 5332921 91763
United StatesSite Not Available
Catalina Research Institute, LLC - Montclair
Montclair 5374232, California 5332921 91763
United StatesSite Not Available
Velocity Clinical Research, San Diego
San Diego 5391811, California 5332921 91942
United StatesSite Not Available
Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
United StatesSite Not Available
Peak Gastroenterology Associates
Colorado Springs 5417598, Colorado 5417618 80907
United StatesSite Not Available
Schiff Center Liver Diseases
Miami, Florida 33136
United StatesSite Not Available
University of Miami
Miami, Florida 33136
United StatesSite Not Available
Panax Clinical Research
Miami Lakes, Florida 33014
United StatesSite Not Available
Covenant Metabolic Specialists, LLC - University Park
University Park, Florida 34201
United StatesSite Not Available
University of Miami
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
Panax Clinical Research
Miami Lakes 4164186, Florida 4155751 33014
United StatesSite Not Available
Piedmont Healthcare-Atlanta
Atlanta, Georgia 30309
United StatesSite Not Available
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia 31904
United StatesSite Not Available
Piedmont Healthcare-Atlanta
Atlanta 4180439, Georgia 4197000 30309
United StatesSite Not Available
Centricity Research Columbus Georgia Multispecialty
Columbus 4188985, Georgia 4197000 31904
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202
United StatesSite Not Available
Mayo Clinic, Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic, Rochester
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Washington University School of Medicine
St Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Columbia University Medical Center
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Centricity Research - Morehead City
Morehead City, North Carolina 28557
United StatesSite Not Available
Lucas Research, Inc.
Morehead City, North Carolina 28557
United StatesSite Not Available
Centricity Research - Morehead City
Morehead City 4480153, North Carolina 4482348 28557
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Nashville General Hospital
Nashville, Tennessee 37209
United StatesSite Not Available
Nashville General Hospital
Nashville 4644585, Tennessee 4662168 37208
United StatesSite Not Available
Texas Clinical Research Institute, LLC
Arlington, Texas 76012
United StatesSite Not Available
Epic Medical Research - Carrollton
Carrollton, Texas 75006
United StatesSite Not Available
The Liver Institute at Methodist Dallas
Dallas, Texas 75203
United StatesSite Not Available
Epic Medical Research - Fort Worth
Fort Worth, Texas 76120
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
Pioneer Research Solutions, Inc.
Houston, Texas 77099
United StatesSite Not Available
American Research Corporation at the Texas Liver Institute
San Antonio, Texas 78215
United StatesActive - Recruiting
Texas Clinical Research Institute, LLC
Arlington 4671240, Texas 4736286 76012
United StatesSite Not Available
Epic Medical Research - Carrollton
Carrollton 4679195, Texas 4736286 75006
United StatesSite Not Available
The Liver Institute at Methodist Dallas
Dallas 4684888, Texas 4736286 75203
United StatesSite Not Available
Epic Medical Research - Fort Worth
Fort Worth 4691930, Texas 4736286 76120
United StatesSite Not Available
Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Pioneer Research Solutions, Inc.
Houston 4699066, Texas 4736286 77099
United StatesSite Not Available
American Research Corporation at the Texas Liver Institute
San Antonio 4726206, Texas 4736286 78215
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.