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A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
Condition: Primary Sclerosing Cholangitis · Sponsor: Ipsen
About this study
This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC) during the double-blind period, an initial 96 week open-label extension (OLE) period, and an optional open-label extension long-term (OLE-LT) period beyond OLE Week 96. PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the study drug, including long-term safety during the open-label extension periods. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.
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 (62)
| Om Research LLC | Lancaster, California, United States | — |
| Cedars-Sinai Medical Center | Los Angeles, California, United States | — |
| University of California, Davis | Sacramento, California, United States | — |
| Sutter Health Van Ness Campus Medical Office Building | San Francisco, California, United States | — |
| Peak Gastroenterology Associates | Colorado Springs, Colorado, United States | — |
| South Denver Gastroenterology,P.C. | Englewood, Colorado, United States | — |
| Rocky Mountain Gastroenterology (RMG) | Littleton, Colorado, United States | — |
| Yale University School Of Medicine - Yale Center For Clinical Investigation | New Haven, Connecticut, United States | — |
| Schiff Center for Liver Diseases - University of Miami | Miami, Florida, United States | — |
| Covenant Research | Sarasota, Florida, United States | — |
| Piedmont Hospital - Piedmont Transplant Institute | Atlanta, Georgia, United States | — |
| Tandem Clinical Research GI | Marrero, Louisiana, United States | — |
+ 50 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05627362