The Effect of Bezafibrate on Cholestatic Itch

Phase 3

• Conditions: Primary Sclerosing Cholangitis; Secondary Sclerosing Cholangitis; Primary Biliary Cholangitis
• Interventions: Drug: Bezafibrate; Drug: Placebo

• Registration Number: NCT02701166
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Status Verified: 2016-03
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-04
• Last Update Submitted: 2016-03-04
• Study First Posted: 2016-03-08
• Last Update Posted: 2016-03-08
• Primary Completion: 2018-02
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• diagnosis of primary biliary cholangitis or primary/secondary sclerosing cholangitis as defined by EASL clinical practice guidelines of cholestasis 2009;
• itch without primary dermatologic abnormalities and with an intensity score of ≥ 5.0 cm on a scale from 0.0 cm (no itch) to 10.0 cm (worst itch possible), scored twice in the week before inclusion.

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Exclusion Criteria

• Concomitant guideline-recommended as well as experimental antipruritic therapy, e.g.

rifampicin, opioid-receptor antagonists (naltrexon, naloxone), serotonin-reuptake inhibitors (sertraline), ondansetron, phenobarbital, propofol, lidocaine, dronabinol, butorphanol, internal or external biliary drainage, extracorporeal albumin dialysis, ultraviolet-B phototherapy; NB. Topical menthol containing agents are allowed, as well as bile salt sequestrants (colesevelam, cholestyramin) as long as taken at least 4 hours before or after intake of the study medication. Incidental use of these agents should be noted by patients in the diary, structural use should be noted on the CRF (section co-medication);

• Pregnancy, women of childbearing potential not using contraception, breast feeding;
• Cholestasis due to obstruction that requires invasive desobstructive treatment within the time scope of the study (5 weeks), such as endoscopic retrograde cholangiopancreaticography (ERCP) or surgical removal of a tumor compressing the bile duct;
• Use of opiates;
• Renal insufficiency (creatinine clearance <60mL/min).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bezafibrate	Bezafibrate	Bezalip retard 400mg tablet
Placebo	Placebo	Placebo 400mg tablet

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a reduction in itch intensity of 50% or more	3 weeks

Secondary Outcome Measures

Name	Time	Method
Serum creatinin kinase	3 weeks
Serum cholesterol	3 weeks
Serum autotaxin activity	3 weeks
Serum liver tests	3 weeks
Serum creatinine	3 weeks

Trial Locations

Locations (9)

Vrije Universiteit Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Radboud Universitair Medisch Centrum; 🇳🇱 Nijmegen, Netherlands

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands

University of Barcelona; 🇪🇸 Barcelona, Spain

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Leids Universitair Medisch Centrum; 🇳🇱 Leiden, Netherlands

Maastricht Universitair Medisch Centrum; 🇳🇱 Maastricht, Netherlands

Erasmus Medisch Centrum; 🇳🇱 Rotterdam, Netherlands