EICHORCondition: Primary Biliary Cholangitis · Sponsor: Ipsen
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease. Primary biliary cholangitis is a slowly progressive disease characterised by damage of 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 scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require a 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). The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease. There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored. Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio). Participants will undergo blood sampling, urine collections, physical examinations, clinical evalu…
This description comes directly from the study's public registry record.
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| Southern California Research Center | Coronado, California, United States | — |
| Topgraphy Health, Inc. | Los Angeles, California, United States | — |
| University of California, Davis | Sacramento, California, United States | — |
| Stanford University Medical Center | Stanford, California, United States | — |
| Peak Gastroenterology Associates | Colorado Springs, Colorado, United States | — |
| Rocky Mountain Gastroenterology | Littleton, Colorado, United States | — |
| International Center for Research | Tampa, Florida, United States | — |
| Delta Research Partners, LLC | West Monroe, Louisiana, United States | — |
| University of Michigan Health System | Ann Arbor, Michigan, United States | — |
| Huron Gastroenterology Associates - Center for Digestive Care | Ypsilanti, Michigan, United States | — |
| South Denver Gastroenterology,P.C. | Englewood, New Jersey, United States | — |
| Southwest Gastroenterology Associates, PC (SWGA) | Albuquerque, New Mexico, United States | — |
+ 48 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06383403