Study evaluating the efficacy of bezafibrate for people suffering of primary sclerosing cholangitis

Phase 1

• Conditions: Adult patients with primary sclerosing cholangitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-001015-23-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-04
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Males or females = 18 and = 75 years
• Large duct PSC verified by retrograde, operative, percutaneous or
magnetic resonance cholangiography (MRC) demonstrating intrahepatic
and /or extrahepatic biliary duct changes consistent with PSC
• Colonoscopy within the last 5 years (or within 3 months if IBD is
associated to PSC) with no cancer nor all-grade dysplasia
• ALP = 1.5 ULN at baseline
• Treatment with UDCA (15-20 mg/kg/d) for = 6 months before
inclusion.
• Using
contraceptive in women of childbearing potential. Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e., less than 1% per year) when used constantly and correctly.
• Affiliation to a social security system (AME excepted)
• Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

• Child-Pugh score B or C
• Ascites or digestive hemorrhage (or history of)
• Total bilirubin in the last 3 months > 50 µmole/L (3 mg/dl)
• Gilbert syndrome defined as unconjugated bilirubinemia > 12 µmol/L
• Albumin in the last 3 months < 35 g/L
• Prothrombin index in the last 3 months < 70%
• Platelets count in the last 3 months < 100000/mm3
• ALT or AST > 5 ULN in the last 3 months
• Prior liver transplantation
• Treatment with a fibrate within the last 3 months inclusion or with a
statin at inclusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified