The Effect of Bezafibrate on Cholestatic Itch

NCT02701166 | Unknown Phase 3

• 1 other identifier: NL48885.018.15
• Study Type: interventional
• Target: 84
• Locations: 2 countries
• Sites: 9

Brief Summary

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

Conditions

Primary Biliary Cholangitis; Primary Sclerosing Cholangitis; Secondary Sclerosing Cholangitis

Keywords

Pruritus; itch; cholestasis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a reduction in itch intensity of 50% or more

  3 weeks

Secondary Outcomes (5)

• Serum liver tests

  3 weeks

• Serum creatinine

  3 weeks

• Serum cholesterol

  3 weeks

• Serum autotaxin activity

  3 weeks

• Serum creatinin kinase

  3 weeks

Study Arms (2)

Bezafibrate

EXPERIMENTAL

Bezalip retard 400mg tablet

Drug: Bezafibrate

Placebo

PLACEBO COMPARATOR

Placebo 400mg tablet

Drug: Placebo

Interventions

Bezafibrate DRUG

bezafibrate 400mg per day

Also known as: bezalip

Bezafibrate

Placebo DRUG

placebo 400mg per day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of primary biliary cholangitis or primary/secondary sclerosing cholangitis as defined by EASL clinical practice guidelines of cholestasis 2009;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Erasmus Medical Center: collaborator
• University Medical Center Groningen: collaborator
• Leiden University Medical Center: collaborator
• UMC Utrecht: collaborator
• Radboud University Medical Center: collaborator
• Maastricht University Medical Center: collaborator
• Free University Medical Center: collaborator
• University of Barcelona: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• Friedrich-Alexander-Universität Erlangen-Nürnberg: collaborator
• Istituto Clinico Humanitas: collaborator

Study Sites (9)

Academic Medical Center

Amsterdam, Netherlands

RECRUITING

Vrije Universiteit Medisch Centrum

Amsterdam, Netherlands

RECRUITING

Universitair Medisch Centrum Groningen

Groningen, Netherlands

RECRUITING

Leids Universitair Medisch Centrum

Leiden, Netherlands

RECRUITING

Maastricht Universitair Medisch Centrum

Maastricht, Netherlands

RECRUITING

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

RECRUITING

Erasmus Medisch Centrum

Rotterdam, Netherlands

RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

RECRUITING

University of Barcelona

Barcelona, Spain

NOT YET RECRUITING

Related Publications (2)

• de Vries E, Bolier R, Goet J, Pares A, Verbeek J, de Vree M, Drenth J, van Erpecum K, van Nieuwkerk K, van der Heide F, Mostafavi N, Helder J, Ponsioen C, Oude Elferink R, van Buuren H, Beuers U; Netherlands Association for the Study of the Liver-Cholestasis Working Group. Fibrates for Itch (FITCH) in Fibrosing Cholangiopathies: A Double-Blind, Randomized, Placebo-Controlled Trial. Gastroenterology. 2021 Feb;160(3):734-743.e6. doi: 10.1053/j.gastro.2020.10.001. Epub 2020 Oct 5.

  PMID: 33031833 DERIVED

• Bolier R, de Vries ES, Pares A, Helder J, Kemper EM, Zwinderman K, Elferink RPO, Beuers U; Netherlands Association for the Study of the Liver (NASL) Cholestatic Liver Diseases Study Group. Fibrates for the treatment of cholestatic itch (FITCH): study protocol for a randomized controlled trial. Trials. 2017 May 23;18(1):230. doi: 10.1186/s13063-017-1966-8.

  PMID: 28535810 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Cholangitis, Sclerosing; Pruritus; Cholestasis

Interventions

Bezafibrate

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cholangitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzoates; Acids, Carbocyclic; Chlorobenzoates; Phenyl Ethers; Ethers; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. Ulrich Beuers

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 8, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

ES (1); NL (8)