Chronic Liver Disease
Conditions
Keywords
Cholestatic, pruritus, of any cause
Brief 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.
Interventions
DRUGcolesevelam
2 times 3 625 mg tablets daily, 3 weeks
DRUGplacebo
2 times 3 625mg tablets daily
Sponsors
Foundation for Liver Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 40% reduction of pruritus according to visual analogue scores | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| improvement in quality of life scores | 3 weeks |
| Reduction in pruritus score/scratch lesions | 3 weeks |
Countries
Netherlands
Outcome results
None listed