Pilot Study of Fenofibrate for PSC

Primary Sclerosing Cholangitis Clinical Trial

Official title:

Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01142323
• Other study ID #: 20100533
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: June 10, 2010
• Last updated: February 3, 2018
• Start date: October 2010
• Est. completion date: December 2012

Study information

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

Clinical Trial Summary

The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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,

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis

Intervention

Drug:
• fenofibrate
160 mg po daily

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Alkaline Phosphatase	Serum alkaline phosphatase will be measured at entry and end of study	6 months
Secondary	Mayo Risk Score for Primary Sclerosing Cholangitis	The Mayo risk score (MRS), which is a composite of several variables (age, bilirubin, albumin, aspartate aminotransferase[AST] and h/o variceal bleeding), will be measured at entry and end of study. The MRS is a mathematically calculated risk score.; MRS does not have a theoretical lower/upper bound (that is, no theoretical minimum and maximum values).; Mayo risk score <=0 indicates low risk of death. MRS between 0 and 2 indicates intermediate risk, and greater than 2 indicates high risk.; There is no known range for this score.	6 months