The Effect of Bezafibrate on Cholestatic Itch
NCT02701166 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2016-03-08
Summary
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.
Conditions
- Primary Biliary Cholangitis
- Primary Sclerosing Cholangitis
- Secondary Sclerosing Cholangitis
Interventions
- DRUG
-
Bezafibrate
bezafibrate 400mg per day
- DRUG
-
placebo 400mg per day
Sponsors & Collaborators
- collaborator OTHER
-
University Medical Center Groningen
collaborator OTHER -
Leiden University Medical Center
collaborator OTHER -
UMC Utrecht
collaborator OTHER -
Radboud University Medical Center
collaborator OTHER -
Maastricht University Medical Center
collaborator OTHER -
Free University Medical Center
collaborator OTHER -
University of Barcelona
collaborator OTHER -
Ludwig-Maximilians - University of Munich
collaborator OTHER -
Friedrich-Alexander-Universität Erlangen-Nürnberg
collaborator OTHER -
Istituto Clinico Humanitas
collaborator OTHER -
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-29
- Primary Completion
- 2018-02-28
- Completion
- 2018-04-30
Countries
- Netherlands
- Spain
Study Locations
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