Use of Fenofibrate for Primary Biliary Cirrhosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00575042
• Date of registration: 13/12/2007
• Prospective Registration: No
• Primary sponsor: University of Florida
• Public title: Use of Fenofibrate for Primary Biliary Cirrhosis
• Scientific title: Pilot Study of Fenofibrate for Primary Biliary Cirrhosis
• Date of first enrolment: August 2007
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00575042
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Cynthia Levy, MD
• Affiliation: University of Florida

Key inclusion & exclusion criteria

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



Age minimum: 21 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Biliary Cirrhosis

Intervention(s)

Drug: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)

Primary Outcome(s)

Serum Level of Alkaline Phosphatase [Time Frame: 1 year]

Secondary ID(s)

405-2006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shionogi Inc.

The PBCers Organization

Results

• Results available: Yes
• Date Posted: 09/01/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00575042