Use of Fenofibrate for Primary Biliary Cirrhosis

Primary Biliary Cirrhosis Clinical Trial

Official title:

Pilot Study of Fenofibrate for Primary Biliary Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575042
• Other study ID #: 405-2006
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2007
• Last updated: February 7, 2018
• Start date: August 2007
• Est. completion date: August 2010

Study information

• Verified date: February 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.

Description:

This is a multicenter open label pilot study to evaluate the efficacy of fenofibrate in 20 patients with PBC treated for 1 year. A randomized design would not be feasible at this stage of the research. Two sites are enrolling patients: University of Florida, Gainesville, and Mayo Clinic Rochester, with the first as the coordinating site. The total number of patients to start treatment will not exceed 20. Our endpoints are 1) surrogate markers of disease activity -serum alkaline phosphatase and immunoglobulin M; 2) a well validated prognostic index -Mayo risk score and 3) the NIDDK quality of life questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Established diagnosis of PBC by serological (positive antimitochondrial antibodies) and/or histological evidence (diagnostic liver biopsy)

• Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year

• Persistent elevation of serum alkaline phosphatase = 2 times the upper limit of normal on two separate measurements

• Female patients of childbearing age should have a pregnancy test done within -days of the beginning of this trial, and should agree to be on adequate contraception throughout the study period

• Signed informed consent after careful review of the information and study details by one of the investigators

Exclusion Criteria

• Hypersensitivity to fenofibrate

• Prisoners and institutionalized subjects

• Pregnant or nursing women

• Anticipated need for liver transplantation in one year (estimated one year survival < 80%) as determined by the Mayo risk score. The Mayo risk score takes into account the patient's age, serum bilirubin, albumin and prothrombin time, as well as presence or absence of peripheral edema.

• Recipients of liver transplantation

• Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites

• Co-existing liver diseases, such as primary sclerosing cholangitis, acute or chronic hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, cholangiocarcinoma

• Acute or chronic renal failure

• Known history of cholecystitis with intact gallbladder

• Current use of statins, as the concomitant use of fibrates and statins would increase the risk of toxicity

Related Conditions & MeSH terms

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

Intervention

Drug:
• Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
160 mg per day for 1 year

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	Shionogi Inc., The PBCers Organization

Country where clinical trial is conducted

United States, 

References & Publications (2)

Levy C, Peter J, Keach J, Petz J, Lindor KD, Cabrera R, et al. Fenofibrate improves liver biochemistries in primary biliary cirrhosis. Hepatology. 2009;50(4 (suppl)):995A.

Levy C, Peter JA, Nelson DR, Keach J, Petz J, Cabrera R, Clark V, Firpi RJ, Morelli G, Soldevila-Pico C, Lindor K. Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid. Aliment Pharmacol T — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Level of Alkaline Phosphatase	We analyzed whether there was a difference in median ALP at 1 year compared to baseline values.	1 year