The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant. The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death). This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant. The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death). This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
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Arizona Liver Health, Tucson, Arizona, United States, 85641
Arkansas Diagnostic Center, PA, Little Rock, Arkansas, United States, 55130
Southern California Research Center, Coronado, California, United States, 92118
Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048
GastroIntestinal BioSciences, Los Angeles, California, United States, 90067
University of California Los Angeles, Los Angeles, California, United States, 90404
University of Colorado, Aurora, Colorado, United States, 80045
Peak Gastroenterology Associates, Colorado Springs, Colorado, United States, 80829
South Denver Gastroenterology, P.C., Englewood, Colorado, United States, 80113
Rocky Mountain Gastroenterology, Littleton, Colorado, United States, 80120
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
Ipsen,
Ipsen Medical Director, STUDY_DIRECTOR, Ipsen
2029-05-31