Tests fenofibrate for primary biliary cirrhosis in people not helped by ursodeoxycholic acid
Tests fenofibrate added to usual treatment in adults with primary biliary cirrhosis.
Plain-language title generated from the registry record
Registry title: Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Key facts
- Where
- Xi'an, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT02823366, who can take part
Where in China
- Xijing HosipitalXi'an, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xijing Hospital of Digestive Diseases
- Trial code
- NCT02823366
- Record updated
- 30 October 2026
- Original description
Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Both lab research and some clinical studies suggest that fenofibrate could improve cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a random, open and parallel clinical research to explore the effect of fenofibrate in the PBC treatment.Read full original descriptionShow less
Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Both lab research and some clinical studies suggest that fenofibrate could improve cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a random, open and parallel clinical research to explore the effect of fenofibrate in the PBC treatment.
Inclusion: Signed informed consent; Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP > 1,5N) and aminotransferase (AST or ALT > 1N) activities; c.Histological hepatic injuries consistent with PBC; Had been treated with UDCA more than 6 months, and failed to achieve a complete biochemical response.
Exclusion: Hepatotoxic drugs use before recruiting; Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis; History of urolithiasis, nephritis or renal failure (clearance of creatinine < 60 ml/mn); Pregnancy or desire of pregnancy; Breast-feeding; History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites); Fenofibrate anaphylaxis.