EICHOR
● Active Not Recruiting
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Condition: Primary Biliary Cirrhosis · Sponsor: Ipsen
About this study
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver disease). PBC is a slowly progressive disease characterized by damage of the bile ducts in the liver, leading to a buildup of bile acids which causes further damage. The liver damage in PBC may lead to scarring (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. The main aim of this study is to determine if elafibranor (the study drug) is better than placebo (a dummy treatment) at decreasing the levels of a specific blood test (alkaline phosphatase) that provides information about participant's disease. This study will also evaluate the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itchy skin (pruritus) and tiredness (fatigue). This study has two main parts: Part 1 will compare a daily dose of elafibranor to a daily dose of placebo and will last between a minimum of one year and a maximum of two years. Part 2, all participants will receive elafibranor for a period of up to 5 years or until the total treatment duration (part 1 and part 2) reaches 6 years, whichever occurs first.
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (115)
| The Institute for Liver Health | Chandler, Arizona, United States | — |
| Keck Medical Center of USC | Los Angeles, California, United States | — |
| Ruane Clinical Research Group Inc. | Los Angeles, California, United States | — |
| Cedars-Sinai Medical Center | Los Angeles, California, United States | — |
| University of California, Davis Medical Center | Sacramento, California, United States | — |
| California Pacific Medical Center - Sutter Pacific Medical Foundation | San Francisco, California, United States | — |
| University of Colorado Denver and Hospital | Aurora, Colorado, United States | — |
| South Denver Gastroenterology, P.C. | Englewood, Colorado, United States | — |
| Yale School of Medicine, Digestive Diseases | New Haven, Connecticut, United States | — |
| Encore Borland-Groover Clinical Research | Jacksonville, Florida, United States | — |
| Schiff Center for Liver Diseases/University of Miami | Miami, Florida, United States | — |
| Digestive Healthcare of Georgia | Atlanta, Georgia, United States | — |
+ 103 more locations — full list on the registry record.
Follow this study
Save your interest here for when the public record changes — results posted, or the study's status changes. Email alerts for this study aren't switched on yet.
We keep this only about this public record, and never email you without alerts being switched on. Want it removed at any time? Email hello@eichor.com. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT04526665