The Effect of Bezafibrate on Cholestatic Itch

Primary Sclerosing Cholangitis Clinical Trial

— FITCH  

Official title:

The Effect of Bezafibrate on Cholestatic Itch

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02701166
• Other study ID #: NL48885.018.15
• Status: Recruiting
• Phase: Phase 3
• First received: March 2, 2016
• Last updated: March 4, 2016
• Start date: February 2016
• Est. completion date: April 2018

Study information

• Verified date: March 2016
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: April 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Biliary Cholangitis
• Primary Sclerosing Cholangitis
• Secondary Sclerosing Cholangitis

Intervention

Drug:
• Bezafibrate
bezafibrate 400mg per day
• Placebo
placebo 400mg per day

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Leids Universitair Medisch Centrum	Leiden
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Netherlands	Radboud Universitair Medisch Centrum	Nijmegen
Netherlands	Erasmus Medisch Centrum	Rotterdam
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Spain	University of Barcelona	Barcelona

Sponsors (12)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Erasmus Medical Center, Free University Medical Center, Friedrich-Alexander-Universität Erlange-Nürnberg, Istituto Clinico Humanitas, Leiden University Medical Center, Ludwig-Maximilians - University of Munich, Maastricht University Medical Center, Radboud University, UMC Utrecht, University Medical Center Groningen, University of Barcelona

Countries where clinical trial is conducted

Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a reduction in itch intensity of 50% or more		3 weeks	No
Secondary	Serum liver tests		3 weeks	No
Secondary	Serum creatinine		3 weeks	Yes
Secondary	Serum cholesterol		3 weeks	No
Secondary	Serum autotaxin activity		3 weeks	No
Secondary	Serum creatinin kinase		3 weeks	Yes