Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Primary Biliary Cirrhosis Clinical Trial

Official title:

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis: a Randomized Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823353
• Other study ID #: KY20151230-4
• Status: Completed
• Phase: Phase 3
• Start date: April 8, 2016
• Est. completion date: June 2022

Study information

• Verified date: September 2022
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: June 2022
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Intervention

Drug:
• Fenofibrate
Fenofibrate 200mg/day
• UDCA
UDCA 13-15mg/kg/day

Locations

Country	Name	City	State
China	Xijing Hosipital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in pruritus.	The symptom of pruritus will be evaluated by questionnaire before enrolment and at the end of the study.	Weeks 48
Other	Change in fatigue.	The symptom of fatigue will be evaluated by Fatigue Impact Scale before enrolment and at the end of the study.	Weeks 48
Other	Change in serum Immunoglobulin M Levels.	Absolute change in serum levels of Immunoglobulin M compared to the baseline.	Week 48
Primary	Rate of patients with complete biochemical response	Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.	Week 48
Secondary	Change in liver biopsy examinations according to conventional Ludwig system.	Histological evolution will be checked by liver biopsy at the end of the study to compare with baseline histological status. The Ludwig histological classification schemes will be used, which categorised the disease into four stages.	Week 48
Secondary	GLOBE risk scores at week 48.	The prognostic scores will be calculated at end of the study by GLOBE scoring system (proposed by Global PBC Study Group), which calculated based on serum values of bilirubin, ALP, albumin and platelet count after 1 year of UDCA therapy and age at baseline.	Week 48
Secondary	Change in liver stiffness status measured by magnetic resonance elastography.	The change of liver stiffness status at the end of the study compared to baseline checked by magnetic resonance elastography.	Week 48
Secondary	Change in serum levels of ALP compared to the baseline.	Absolute change in serum levels of ALP compared to the baseline.	Weeks 0, 4, 8, 12, 24, and 48
Secondary	Change in serum levels of bilirubin compared to the baseline.	Absolute change in serum levels of bilirubin compared to the baseline.	Weeks 0, 4, 8, 12, 24, and 48
Secondary	Change in serum levels of transaminase compared to the baseline.	Absolute change in serum levels of transaminase compared to the baseline.	Weeks 0, 4, 8, 12, 24, and 48