The Effect of Bezafibrate on Cholestatic Itch (FITCH)
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ClinicalTrials.gov Identifier: NCT02701166 |
Recruitment Status : Unknown
Verified March 2016 by Ruth Bolier, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was: Recruiting
First Posted : March 8, 2016
Last Update Posted : March 8, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Biliary Cholangitis Primary Sclerosing Cholangitis Secondary Sclerosing Cholangitis | Drug: Bezafibrate Drug: Placebo | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Bezafibrate
Bezalip retard 400mg tablet
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Drug: Bezafibrate
bezafibrate 400mg per day
Other Name: bezalip |
Placebo Comparator: Placebo
Placebo 400mg tablet
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Drug: Placebo
placebo 400mg per day |
- Proportion of patients with a reduction in itch intensity of 50% or more [ Time Frame: 3 weeks ]
- Serum liver tests [ Time Frame: 3 weeks ]
- Serum creatinine [ Time Frame: 3 weeks ]
- Serum cholesterol [ Time Frame: 3 weeks ]
- Serum autotaxin activity [ Time Frame: 3 weeks ]
- Serum creatinin kinase [ Time Frame: 3 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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).

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
Netherlands | |
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 | |
Spain | |
University of Barcelona | Not yet recruiting |
Barcelona, Spain | |
Contact: Albert Parés, dr. +34-93-2275753 pares@ub.edu |
Responsible Party: | Ruth Bolier, prof. dr. Ulrich Beuers, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
ClinicalTrials.gov Identifier: | NCT02701166 |
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 |
Pruritus itch cholestasis |
Cholangitis Cholangitis, Sclerosing Liver Cirrhosis, Biliary Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Cholestasis, Intrahepatic Cholestasis Liver Diseases |
Liver Cirrhosis Fibrosis Pathologic Processes Bezafibrate Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |