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

• Register: EUCTR
• Last refreshed on: 14 September 2015
• Main ID: EUCTR2014-001438-27-NL
• Date of registration: 20/07/2015
• Prospective Registration: Yes
• Primary sponsor: Academic Medical Center
• Public title: The effect of bezafibrate on itch in a subset of liver diseases
• Scientific title: The effect of bezafibrate on cholestatic itch - FITCH
• Date of first enrolment: 19/08/2015
• Target sample size: 84
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001438-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Netherlands

Contacts

• Name: Academic Medical Center
• Affiliation: Academic Medical Center

• Name: Academic Medical Center
• Affiliation: Academic Medical Center

Key inclusion & exclusion criteria

Inclusion criteria:
- age > 18 y
- 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Trade Name: Bezalip
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: day 0, 21, 35

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

Secondary ID(s)

48885

Source(s) of Monetary Support

Academic Medical Center Amsterdam