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-ES
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 84
- age > 18 years
- 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
- 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
- Secondary Outcome Measures
Name Time Method