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Fenofibrate in PSC

The effect of Fenofibrate on the Clinical Outcome of primary Sclerosing Cholangitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200427047225N1
Enrollment
30
Registered
2020-06-02
Start date
2020-05-03
Completion date
Unknown
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary sclerosing cholangitis disease. Hepatic sclerosis

Interventions

Intervention 1: Intervention group: Fifteen patients aged 18 to 75 years with primary sclerosing cholangitis are initially assessed in terms of liver enzyme levels, pruritus, and Mayo risk score. Pati

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: chronic cholestatic liver disease for atleast 6 month alkaline phosphatase serum level atleast 1.5x upper limit normal multi focal dilation and stricture in intra/extra hepatic billiary ducts on MRCP or liver biopsy confirmed PSC (fibrosing cholangitis, ductopenia, peei portal inflammation or biliary fibrosis)

Exclusion criteria

Exclusion criteria: concurrent advanced malignancy or severe cardiopulmonary disease with less than 2 years survival inlammatory intestinal diseasethat need medical therapy during 3 month from begining (except miantenance therapy with 5-ASA) candidate for liver transplant and survival less than 80% in 2 years according to MAYO risk score portal hypertension complicatin such as variceal bleeding ascitis liver encephalopathy pregnancy or breast feeding age under 18 years or above 75 years other liver disease diagonosis sucg as chronic alcoholic livera disease, B or C hepatitis, auto immune hepatitis, primary biliary cirrosis, hemochromatosis, wilson disease, congenital biliary disease or cholangiocarcinoma previous biliary stone or ductal manipulation, cholecycstectomy or other biliary drainage before PSC confirmed ascending biliary cholangitis need more than twice a years admission patient who di not allow fenofibrate allergy or intolerance or side effects concurrent use of local or systemic anti-itch agents such as anti histamins

Design outcomes

Primary

MeasureTime frame
Serum Alkaline Phosphatase. Timepoint: Measurement of Serum Alkaline APhosphatase at base and after 6 month Therapy with Fenofibrate. Method of measurement: Chemistry Laboratory.

Secondary

MeasureTime frame
Serum level of Billirubin. Timepoint: At base and after 6 month Therapy with Fenofibrate. Method of measurement: Chemistry Laboratory.;Pruritis. Timepoint: At base and after 6 month Therapy with Fenofibrate. Method of measurement: Questionary.;Mayo Risk Score. Timepoint: At base and after 6 month Therapy with Fenofibrate. Method of measurement: Mayo Risk Score system.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMozhde Mosala

Shahid Beheshti University of Medical Sciences

mohd109@gmail.com+98 21 4443 8262

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026