The effect of bezafibrate on itch in a subset of liver diseases

Conditions: Primary biliary cirrhosis (PBC)Primary sclerosing cholangitis (PSC)Secondary sclerosing cholangitis (SSC)
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2014-001438-27-NL

Lead Sponsor: Academic Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 84

Inclusion Criteria

- age > 18 y
- understanding of Dutch, German, English, Spanish or Italian language
- Diagnosis of PBC, PSC or SSC as defined by EASL clinical practice guidelines of cholestasis 2009
- itch without primary dermatologic abnormalities and with an intensity score of 5 of higher on a scale from 0 to 10, scored twice within the week before start of the treatment
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 84
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- concomitant antipruritic therapy
- pregnancy
- cholestasis due to obstruction that requires invasive desobstructive treatment within the time scope of the study (5 weeks), such as ERCP or surgery
- use of opiates

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the effect of bezafibrate on itch in cholestatic patients;Secondary Objective: - to test the effect of bezafibrate on serum autotaxin activity in cholestatic patients<br>- to screen for hepatotoxic and other side effects (rhabdomyolysis, modifications of the lipid profile, nephrotoxic effects) of bezafibrate in cholestatic liver diseases<br>- to determine the effect of bezafibrate on fatigue and quality of life scores in cholestatic patients;Primary end point(s): proportion of patients reaching a 50% or more reduction in itch intensity VAS score after 21 days of treatment;Timepoint(s) of evaluation of this end point: day 0 and 21

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - 5D itch score questionnaire<br>- serum autotaxin activity<br>serum liver, kidney function and lipid profile parameters (AST, ALT, ALP, gGT, albumin, creatinin, ureum, CK, VLDL, LDL, HDL cholesterol, triglycerides)<br>- number of adverse and serious adverse events during and after treatment<br>-fatigue and quality of life;Timepoint(s) of evaluation of this end point: day 0, 21, 35