COPE-trial: Colesevelam versus placebo in cholestatic pruritus, a double-blind placebo-controlled study

Phase 3

Recruiting

• Conditions: cholestatic pruritus; itch in cholestatic liver disease; 10019654

• Registration Number: NL-OMON31774
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 38

Inclusion Criteria

patients with pruritus as a result of a cholestatic disorder
age above 18
informed consent

Exclusion Criteria

Use of cholestyramine
Pregnancy
Inability to understand or speak Dutch language
Malignancy/Life expectancy<6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>40% reduction of pruritus according to visual analogue scores, comparison of<br /><br>mean VAS score on T=18,19,20 to mean VAS score on T=-2, -1, 0.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>Improvement in quality of life scores (T=0 compared to T=20)<br /><br>Reduction in pruritus score/scratch lesions (T=0 compared to T=20)</p><br>