The effect of bezafibrate on itch in a subset of liver diseases

The effect of bezafibrate on cholestatic itch - FITCH

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001438-27-ES

Enrollment

Registered

2017-10-10

Start date

2017-11-29

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC)

Interventions

Trade Name: Bezalip Pharmaceutical Form: Coated tablet INN or Proposed INN: BEZAFIBRATE CAS Number: 41859-67-0 Concentration unit: mg mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age > 18 years - understanding of Dutch, German, English, Spanish or Italian language - Diagnosis of PBC, PSC or SSC as defined by EASL clinical practice guidelines of cholestasis 2009 - itch without primary dermatologic abnormalities and with an intensity score of 5 of higher on a scale from 0 to 10, scored twice within the week before start of the treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 84 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - concomitant antipruritic therapy - pregnancy - cholestasis due to obstruction that requires invasive desobstructive treatment within the time scope of the study (5 weeks), such as ERCP or surgery - use of opiates

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate the effect of bezafibrate on itch in cholestatic patients; Secondary Objective: - to test the effect of bezafibrate on serum autotaxin activity in cholestatic patients - to screen for hepatotoxic and other side effects (rhabdomyolysis, modifications of the lipid profile, nephrotoxic effects) of bezafibrate in cholestatic liver diseases - to determine the effect of bezafibrate on fatigue and quality of life scores in cholestatic patients ;Primary end point(s): proportion of patients reaching a 50% or more reduction in itch intensity VAS score after 21 days of treatment;Timepoint(s) of evaluation of this end point: day 0 and 21	—

Measure

Time frame

Main Objective: to evaluate the effect of bezafibrate on itch in cholestatic patients; Secondary Objective: - to test the effect of bezafibrate on serum autotaxin activity in cholestatic patients - to screen for hepatotoxic and other side effects (rhabdomyolysis, modifications of the lipid profile, nephrotoxic effects) of bezafibrate in cholestatic liver diseases - to determine the effect of bezafibrate on fatigue and quality of life scores in cholestatic patients ;Primary end point(s): proportion of patients reaching a 50% or more reduction in itch intensity VAS score after 21 days of treatment;Timepoint(s) of evaluation of this end point: day 0 and 21

—

Secondary

Measure	Time frame
Secondary end point(s): - 5D itch score questionnaire - serum autotaxin activity serum liver, kidney function and lipid profile parameters (AST, ALT, ALP, gGT, albumin, creatinin, ureum, CK, VLDL, LDL, HDL cholesterol, triglycerides) - number of adverse and serious adverse events during and after treatment -fatigue and quality of life ;Timepoint(s) of evaluation of this end point: day 0, 21, 35	—

Countries

Netherlands, Spain

Contacts

Public ContactAcademic Medical Center

Academic Medical Center

u.h.beuers@amc.nl00310205662422

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026