Condition: Primary Biliary Cholangitis (PBC) · Sponsor: Ipsen
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.
This description comes directly from the study's public registry record.
Ipsen Clinical Study Enquiries · See e mail · clinical.trials@ipsen.com
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| Arizona Liver Health | Tucson, Arizona, United States | Recruiting |
| Arkansas Diagnostic Center, PA | Little Rock, Arkansas, United States | Terminated |
| Southern California Research Center | Coronado, California, United States | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles, California, United States | Active Not Recruiting |
| GastroIntestinal BioSciences | Los Angeles, California, United States | Recruiting |
| University of California Los Angeles | Los Angeles, California, United States | Withdrawn |
| University of California Davis Medical Center | Sacramento, California, United States | Recruiting |
| University of Colorado | Aurora, Colorado, United States | Recruiting |
| Peak Gastroenterology Associates | Colorado Springs, Colorado, United States | Recruiting |
| South Denver Gastroenterology, P.C. | Englewood, Colorado, United States | Recruiting |
| Rocky Mountain Gastroenterology | Littleton, Colorado, United States | Recruiting |
| University Of Miami School Of Medicine, Center For Liver Diseases | Miami, Florida, United States | Recruiting |
+ 174 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06016842