Colesevelam Versus Placebo in Cholestatic Pruritus (COPE)

Foundation for Liver Research

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Liver Disease

Treatments: Drug: colesevelam; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00756171

COPE_08

Details and patient eligibility

About

38 patients with pruritus due to chronic cholestatic liver disease will be evaluated in an investigator initiated, multicenter, double-blind, placebo-controlled, 3-week study assessing the effects of colesevelam on pruritus. Colesevelam is an oral, non-absorbable bile-acid sequestrant much more potent than cholestyramine but free of adverse effects. It is registered as a lipid lowering agent. The intensity of symptoms will be scored by means of daily Visual Analogue Scales (VAS). Fatigue, quality of life and cutaneous scratch lesions will also be evaluated using quantitative instruments.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• use of cholestyramine
• pregnancy
• inability to understand or speak Dutch language
• malignancy/life expectancy <6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Verum; colesevelam

Treatment:

Drug: colesevelam

2

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo