Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA

Primary Biliary Cirrhosis Clinical Trial

Official title:

A Randomized Controlled Clinical Trial on the Efficacy and Safety of Fenofibrate Combined With Ursodeoxycholic Acid in PBC Patients With an Incomplete Biochemical Response to UDCA

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02965911
• Other study ID #: BJ302-FGRXGB-002
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: January 2016
• Est. completion date: September 8, 2021

Study information

• Verified date: September 2021
• Source: Beijing 302 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.

Description:

Primary biliary cholangitis is a chronic cholestatic liver disease, ursodeoxycholic acid (UDCA) is the only drug approved for the treatment of PBC. Although UDCA can improve the clinical outcomes in patients with PBC, about 40% of PBC patients show an incomplete biochemical response to this treatment, accordingly have a significantly increased risk of developing liver transplantation or death. Therefor there is a urgently needed for better therapies for these patients. The development of new treatments is therefore needed. The Fenofibrate is the candidate, there is now a substantial body of circumstantial evidence supporting that Fenofibrate is well tolerated and can improve biochemical response in PBC patients with incompleted response to UDCA. The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 8, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. PBC Patient , previous treatment with UDCA 13-15 mg/kg/day for at least 1 year, showed incomplete biochemical response;

2. Patients who showing an incomplete biochemical response to UDCA as defined by: ALP > 3ULN,AST> 2N ,total bilirubin >17 µmol/l after = 12 months of UDCA at the dose of 13 - 15 mg/kg/day. 3,signed informed consent after careful review of information and study details.

Exclusion Criteria:

1. Hypersensitivity to fenofibrate

2. Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids.

3. Decompensation PBC, such as recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites

4. Anticipated need for liver transplantation within one year

5. 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

6. Acute or chronic renal failure

7. Known history of cholecystitis with intact gallbladder

8. Pregnant or nursing women

Related Conditions & MeSH terms

• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Intervention

Drug:
• Fenofibrate
Fenofibrate is a drug of the fibrate class. it reduces both low-density lipoprotein (LDL) and very low density lipoprotein (VLDL) levels, as well as increasing high-density lipoprotein (HDL) levels and reducing triglyceride levels.
• UDCA
Ursodeoxycholic acid,the abbreviation UDCA, is one of the secondary bile acids, which are metabolic byproducts of intestinal bacteria,it is the only FDA approved drug to treat PBC.

Locations

Country	Name	City	State
China	Beijing 302 hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Level of Alkaline Phosphatase(ALP) value	To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.	12 months
Secondary	Total bilirubin(TBIL) value	To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.	12 months
Secondary	Aspartate aminotransferase(AST) value	To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.	12 months
Secondary	Serum Level of Gamma-glutamyl transpeptidase (GGT) value	To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.	12 months