The effect of bezafibrate on itch in liver disease

Recruiting

Conditions: Primary biliary cirrhosis (PBC)Primary sclerosing cholangitis (PSC)Secondary sclerosing cholangitis (SSC)

Registration Number: NL-OMON22138

Lead Sponsor: Academic Medical Center, Amsterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 84

Inclusion Criteria

Age ≥ 18 years;
-Understanding of Dutch, English, German, Spanish or Italian language;

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);

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Itch intensity score on a visual analogue scale (VAS)

Secondary Outcome Measures

Name	Time	Method
-5D itch score: questionnaire for the evaluation of the 5 dimensions of itch and it’s impact on quality of life: duration, degree, direction, disability and distribution of itching;<br /><br>-Serum ATX activity before, during and after treatment; <br /><br>-Serum liver, kidney function and lipid profile parameters: AST, ALT, AP, γGT, albumin, creatinine, ureum, CK, VLDL-, LDL- and HDL-cholesterol and triglycerides before and after treatment;<br /><br>-Number of adverse and serious adverse events during and within two weeks after treatment;<br /><br>-The effect on fatigue and quality of life will be evaluated using the Liver Disease Symptom Index 2.0 questionnaire.