Colesevelam Versus Placebo in Cholestatic Pruritus

Last updated: December 17, 2012
Sponsor: Foundation for Liver Research
Overall Status: Completed

Phase

2/3

Condition

Hives (Urticaria)

Hepatitis C; Chronic

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT00756171
COPE_08
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients with pruritus as a result of a cholestatic disorder

  • age above 18 years

  • informed consent

Exclusion

Exclusion Criteria:

  • use of cholestyramine

  • pregnancy

  • inability to understand or speak Dutch language

  • malignancy/life expectancy <6 months

Study Design

Total Participants: 38
Study Start date:
September 01, 2008
Estimated Completion Date:
December 31, 2009

Connect with a study center

  • Amsterdam Medical Center

    Amsterdam,
    Netherlands

    Site Not Available

  • Erasmus Medical Center

    Rotterdam,
    Netherlands

    Site Not Available

  • University Medical Center Utrecht

    Utrecht,
    Netherlands

    Site Not Available

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