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The Effect of Bezafibrate on Cholestatic Itch (FITCH)

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ClinicalTrials.gov Identifier: NCT02701166
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : March 8, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.

Condition or disease Intervention/treatment Phase
Primary Biliary Cholangitis Primary Sclerosing Cholangitis Secondary Sclerosing Cholangitis Drug: Bezafibrate Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Bezafibrate on Cholestatic Itch
Study Start Date : February 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : April 2018

Arms and Interventions

Arm Intervention/treatment
Experimental: Bezafibrate
Bezalip retard 400mg tablet
Drug: Bezafibrate
bezafibrate 400mg per day
Other Name: bezalip
Placebo Comparator: Placebo
Placebo 400mg tablet
Drug: Placebo
placebo 400mg per day

Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients with a reduction in itch intensity of 50% or more [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Serum liver tests [ Time Frame: 3 weeks ]
  2. Serum creatinine [ Time Frame: 3 weeks ]
  3. Serum cholesterol [ Time Frame: 3 weeks ]
  4. Serum autotaxin activity [ Time Frame: 3 weeks ]
  5. Serum creatinin kinase [ Time Frame: 3 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701166

Academic Medical Center Recruiting
Amsterdam, Netherlands
Contact: Ulrich Beuers, prof. dr.    +31205662422    u.h.beuers@amc.uva.nl   
Contact: Ruth Bolier    +31205668701    a.r.bolier@amc.uva.nl   
Principal Investigator: Ulrich Beuers, prof. dr.         
Sub-Investigator: Elsemieke de Vries         
Vrije Universiteit Medisch Centrum Recruiting
Amsterdam, Netherlands
Contact: Karin van Nieuwkerk, dr.    +31-20-4440613    cmj.vannieuwkerk@vumc.nl   
Contact: Ineke Jansen    +31-20-4449455    a.jansen1@vumc.nl   
Universitair Medisch Centrum Groningen Recruiting
Groningen, Netherlands
Contact: Marleen de Vree, dr.    +31-6-55256255    j.m.l.de.vree@umcg.nl   
Contact: Lyda Engelsman    +31-50-3614996    a.f.engelsman@umcg.nl   
Leids Universitair Medisch Centrum Recruiting
Leiden, Netherlands
Contact: Bart van Hoek, prof. dr.    +31-71-5263507    b.van_hoek@lumc.nl   
Contact: Lida Beneken Kolmer    +31-71-5261188    a.beneken_kolmer@lumc.nl   
Maastricht Universitair Medisch Centrum Recruiting
Maastricht, Netherlands
Contact: Peter Jansen, prof. dr.    +31-43-3876543    plm.jansen@maastrichtuniversity.nl   
Contact: Tine Horsten    +31-43-3874436    t.horsten@mumc.nl   
Radboud Universitair Medisch Centrum Recruiting
Nijmegen, Netherlands
Contact: Joost Drenth, prof. dr.    +31-24-3613999    joostphdrenth@cs.com   
Contact: Sonja Cuppen    +31-24-3619190    researchunit.mdl@radboudumc.nl   
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands
Contact: Henk van Buuren, dr.    +31-10-7035942    h.vanbuuren@erasmusmc.nl   
Contact: Maren Harms    +31-10-7038922    m.h.harms@erasmusmc.nl   
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands
Contact: Karel van Erpecum, dr.    +31-88-7555555    k.j.vanerpecum@umcutrecht.nl   
Contact: Janneke van den Brink    +31-88-7557973    j.vandenbrink@umcutrecht.nl   
University of Barcelona Not yet recruiting
Barcelona, Spain
Contact: Albert Parés, dr.    +34-93-2275753    pares@ub.edu   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center
University Medical Center Groningen
Leiden University Medical Center
UMC Utrecht
Radboud University
Maastricht University Medical Center
Free University Medical Center
University of Barcelona
Ludwig-Maximilians - University of Munich
Friedrich-Alexander-Universität Erlange-Nürnberg
Istituto Clinico Humanitas
More Information

Responsible Party: Ruth Bolier, prof. dr. Ulrich Beuers, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02701166     History of Changes
Other Study ID Numbers: NL48885.018.15
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ruth Bolier, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Additional relevant MeSH terms:
Cholangitis, Sclerosing
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Liver Diseases
Liver Cirrhosis
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents