The Effect of Bezafibrate on Cholestatic Itch

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02701166
• Date of registration: 02/03/2016
• Prospective Registration: No
• Primary sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Public title: The Effect of Bezafibrate on Cholestatic Itch FITCH
• Scientific title: The Effect of Bezafibrate on Cholestatic Itch
• Date of first enrolment: February 2016
• Target sample size: 84
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02701166
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Netherlands, Spain

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Secondary Sclerosing Cholangitis

Primary Sclerosing Cholangitis

Primary Biliary Cholangitis

Intervention(s)

Drug: Placebo

Drug: Bezafibrate

Primary Outcome(s)

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

Secondary Outcome(s)

Serum cholesterol [Time Frame: 3 weeks]

Serum creatinine [Time Frame: 3 weeks]

Serum autotaxin activity [Time Frame: 3 weeks]

Serum creatinin kinase [Time Frame: 3 weeks]

Serum liver tests [Time Frame: 3 weeks]

Secondary ID(s)

NL48885.018.15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Istituto Clinico Humanitas

Free University Medical Center

Ludwig-Maximilians - University of Munich

University Medical Center Groningen

Erasmus Medical Center

University of Barcelona

Friedrich-Alexander-Universität Erlange-Nürnberg

Leiden University Medical Center

Radboud University

UMC Utrecht

Maastricht University Medical Center