Overview

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Status:
Unknown status
Trial end date:
2018-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Treatments:
Fenofibrate
Ursodeoxycholic Acid
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.