No registrations found.
ID
Source
Brief title
Health condition
Primary biliary cirrhosis (PBC)
Primary sclerosing cholangitis (PSC)
Secondary sclerosing cholangitis (SSC)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Itch intensity score on a visual analogue scale (VAS)
Secondary outcome
-5D itch score: questionnaire for the evaluation of the 5 dimensions of itch and it’s impact on quality of life: duration, degree, direction, disability and distribution of itching;
-Serum ATX activity before, during and after treatment;
-Serum liver, kidney function and lipid profile parameters: AST, ALT, AP, γGT, albumin, creatinine, ureum, CK, VLDL-, LDL- and HDL-cholesterol and triglycerides before and after treatment;
-Number of adverse and serious adverse events during and within two weeks after treatment;
-The effect on fatigue and quality of life will be evaluated using the Liver Disease Symptom Index 2.0 questionnaire.
Study objective
Bezafibrate alleviates itch complaints in patients with cholestatic liver disease.
Study design
start of treatment (day 0); end of treatment (day 21); follow-up (day 35)
Intervention
bezafibrate 400mg once daily for 3 weeks
Ruth Bolier
Meibergdreef 69-71
Amsterdam 1105 BK
The Netherlands
T: +31-20-5668701
E: a.r.bolier@amc.uva.nl
Ruth Bolier
Meibergdreef 69-71
Amsterdam 1105 BK
The Netherlands
T: +31-20-5668701
E: a.r.bolier@amc.uva.nl
Inclusion criteria
-Age ≥ 18 years;
-Understanding of Dutch, English, German, Spanish or Italian language;
-Diagnosed with primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC) or secondary sclerosing cholangitis (as defined by EASL clinical practice guidelines of cholestasis 2009 [19]).
-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 tumour compressing the bile duct;
-Use of opiates;
-Renal insufficiency (creatinine clearance <60mL/min per 1.73m2).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5327 |
| NTR-old | NTR5436 |
| CCMO | NL48885.018.15 |
| OMON | NL-OMON42182 |