To evaluate the effect of bezafibrate in cholestatic pruritus.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of patients with a 50% reduction of itch intensity on a visual
analogue scale (VAS) after bezafibrate treatment, compared to placebo.
Secondary outcome
- To test the effect of bezafibrate on serum autotaxin (ATX) 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.
Background summary
Several studies on the effect of fibrates in PBC patients report that
bezafibrate relieves pruritus (itch) complaints, but this remains to be proven
in a randomized controlled trial including patients with cholestatic liver
diseases other than PBC that are accompanied by pruritus.
Study objective
To evaluate the effect of bezafibrate in cholestatic pruritus.
Study design
Multi-centre investigator initiated double blind randomized placebo controlled
trial.
Intervention
Bezafibrate 400mg or placebo
Study burden and risks
- Study medicine: in case series and pilot studies, bezafibrate has shown to be
safe and effective in PBC patients with a suboptimal response to standard UDCA
treatment;
- Other interventions: before, during and after the treatment, patients will be
asked to keep track of their itch intensity by means of a visual analogue
scale (VAS). In addition, patients will be asked three times to fill in two
questionnaires. This is believed to carry a minor burden and no risks and
moreover contribute to medication compliance during the study. Sampling of
peripheral venous blood will be performed three times and carries the risk of
hematoma (common, low burden) and phlebitis (rare, low-intermediate burden).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
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
- renal insufficiency (creatinine clearance <60mL/min)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-001438-27-NL |
| CCMO | NL48885.018.15 |
| OMON | NL-OMON22138 |