Clinical trial NCT02823353: Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Official title: Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis: a Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Biliary Cirrhosis
Keywords: PBC
UDCA
Fenofibrate
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (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.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. 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/ALT \> 1N) activities; c.Histological hepatic injuries consistent with PBC.

Exclusion Criteria:

1. Pregnancy or desire of pregnancy.
2. Breast-feeding.
3. 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
4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
5. History of urolithiasis, nephritis or renal failure (clearance of creatinine \< 60 ml/mn).
6. Hepatotoxic drugs use before recruiting.
7. Fenofibrate anaphylaxis.

Primary outcomes:
measure: Rate of patients with complete biochemical response
timeFrame: Week 48
Secondary outcomes:
measure: Change in liver biopsy examinations according to conventional Ludwig system.
timeFrame: Week 48
measure: GLOBE risk scores at week 48.
timeFrame: Week 48
measure: Change in liver stiffness status measured by magnetic resonance elastography.
timeFrame: Week 48
measure: Change in serum levels of ALP compared to the baseline.
timeFrame: Weeks 0, 4, 8, 12, 24, and 48
measure: Change in serum levels of bilirubin compared to the baseline.
timeFrame: Weeks 0, 4, 8, 12, 24, and 48
measure: Change in serum levels of transaminase compared to the baseline.
timeFrame: Weeks 0, 4, 8, 12, 24, and 48
Other outcomes:
measure: Change in pruritus.
timeFrame: Weeks 48
measure: Change in fatigue.
timeFrame: Weeks 48
measure: Change in serum Immunoglobulin M Levels.
timeFrame: Week 48
Locations:
city: Xi'an
country: China
facility: Xijing Hosipital
state: Shaanxi
Study officials:
References: