NCT02823366RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 28 Jan 2016
- Start date
- 1 Jan 2016
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT02823366
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 104
- From 1 Jan 2016 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hepatotoxic drugs use before recruiting.
Other illness
- 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.
Lab values
- History of urolithiasis, nephritis or renal failure (clearance of creatinine \< 60 ml/mn).
Other
- Pregnancy or desire of pregnancy.
- Breast-feeding.
- History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
- Fenofibrate anaphylaxis.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing Hosipital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.