The Effect of Bezafibrate on Cholestatic Itch (FITCH)

March 4, 2016 updated by: Ruth Bolier, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Academic Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ulrich Beuers, prof. dr.
        • Sub-Investigator:
          • Elsemieke de Vries
      • Amsterdam, Netherlands
        • Recruiting
        • Vrije Universiteit Medisch Centrum
        • Contact:
        • Contact:
      • Groningen, Netherlands
        • Recruiting
        • Universitair Medisch Centrum Groningen
        • Contact:
        • Contact:
      • Leiden, Netherlands
        • Recruiting
        • Leids Universitair Medisch Centrum
        • Contact:
        • Contact:
      • Maastricht, Netherlands
      • Nijmegen, Netherlands
      • Rotterdam, Netherlands
      • Utrecht, Netherlands
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • University of Barcelona
        • Contact:
          • Albert Parés, dr.
          • Phone Number: +34-93-2275753
          • Email: pares@ub.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of primary biliary cholangitis or primary/secondary sclerosing cholangitis as defined by EASL clinical practice guidelines of cholestasis 2009;
  • itch without primary dermatologic abnormalities and with an intensity score of ≥ 5.0 cm on a scale from 0.0 cm (no itch) to 10.0 cm (worst itch possible), scored twice in the week before inclusion.

Exclusion Criteria:

  • Concomitant guideline-recommended as well as experimental antipruritic therapy, e.g.

rifampicin, opioid-receptor antagonists (naltrexon, naloxone), serotonin-reuptake inhibitors (sertraline), ondansetron, phenobarbital, propofol, lidocaine, dronabinol, butorphanol, internal or external biliary drainage, extracorporeal albumin dialysis, ultraviolet-B phototherapy; NB. Topical menthol containing agents are allowed, as well as bile salt sequestrants (colesevelam, cholestyramin) as long as taken at least 4 hours before or after intake of the study medication. Incidental use of these agents should be noted by patients in the diary, structural use should be noted on the CRF (section co-medication);

  • Pregnancy, women of childbearing potential not using contraception, breast feeding;
  • Cholestasis due to obstruction that requires invasive desobstructive treatment within the time scope of the study (5 weeks), such as endoscopic retrograde cholangiopancreaticography (ERCP) or surgical removal of a tumor compressing the bile duct;
  • Use of opiates;
  • Renal insufficiency (creatinine clearance <60mL/min).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bezafibrate
Bezalip retard 400mg tablet
Drug: Bezafibrate
bezafibrate 400mg per day
Other Names:
  • bezalip
Placebo Comparator: Placebo
Placebo 400mg tablet
Drug: Placebo
placebo 400mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with a reduction in itch intensity of 50% or more
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum liver tests
Time Frame: 3 weeks
3 weeks
Serum creatinine
Time Frame: 3 weeks
3 weeks
Serum cholesterol
Time Frame: 3 weeks
3 weeks
Serum autotaxin activity
Time Frame: 3 weeks
3 weeks
Serum creatinin kinase
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Radboud University Medical Center
University Medical Center Groningen
Maastricht University Medical Center
UMC Utrecht
Erasmus Medical Center
Ludwig-Maximilians - University of Munich
Leiden University Medical Center
Istituto Clinico Humanitas
University of Barcelona
Free University Medical Center
Friedrich-Alexander-Universität Erlangen-Nürnberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL48885.018.15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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