Pilot Study of Fenofibrate for PSC

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01142323
• Date of registration: 10/06/2010
• Prospective Registration: Yes
• Primary sponsor: University of Miami
• Public title: Pilot Study of Fenofibrate for PSC
• Scientific title: Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis
• Date of first enrolment: October 2010
• Target sample size: 8
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01142323
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female patients of 18 to 75 years old

- Confirmed diagnosis of PSC including typical findings of stricturing and dilatations
of the intra and/or extrahepatic biliary ducts in radiographic exam, (endoscopic
retrograde cholangiopancreatography -ERCP, percutaneous cholangiogram - PTC or
magnetic resonance cholangiopancreatography- MRCP)

- Serum alkaline phosphatase levels elevated to at least 1.5 times the upper limit of
normal.

Exclusion Criteria:

- Hypersensitivity to fenofibrate

- Prisoners and institutionalized subjects

- Pregnant or nursing women

- Anticipated need for liver transplantation in one year

- Recipients of liver transplantation

- Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites

- Co-existing liver diseases including auto-immune and viral hepatitis

- Acute or chronic renal failure, defined as glomerular filtration rate (GFR)< 60
ml/min, GFR calculated using the Modification of Diet in Renal Disease (MDRF) GFR
calculator

- Known cholecystitis

- Current use of statins

- Current use of coumadin anticoagulant therapy

- Previous history of, or known high risk for, venous thromboembolism,



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sclerosing Cholangitis

Intervention(s)

Drug: fenofibrate

Primary Outcome(s)

Serum Alkaline Phosphatase [Time Frame: 6 months]

Secondary Outcome(s)

Mayo Risk Score for Primary Sclerosing Cholangitis [Time Frame: 6 months]

Secondary ID(s)

20100533

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Florida

Results

• Results available: Yes
• Date Posted: 23/04/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01142323