The effect of bezafibrate on cholestatic itch

Phase 2

Completed

• Conditions: primary biliary cirrhosis; primary sclerosing cholangitis; 10019654

• Registration Number: NL-OMON42182
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 52

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

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
- renal insufficiency (creatinine clearance <60mL/min)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of patients with a 50% reduction of itch intensity on a visual<br /><br>analogue scale (VAS) after bezafibrate treatment, compared to placebo.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To test the effect of bezafibrate on serum autotaxin (ATX) activity in<br /><br>cholestatic patients;<br /><br>- To screen for hepatotoxic and other side effects (rhabdomyolysis,<br /><br>modifications of the lipid profile, nephrotoxic effects) of bezafibrate in<br /><br>cholestatic liver diseases;<br /><br>- To determine the effect of bezafibrate on fatigue and quality of life scores<br /><br>in cholestatic patients.</p><br>