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The effect of bezafibrate on itch in liver disease


- candidate number22533
- NTR NumberNTR5436
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-aug-2015
- Secondary IDsNL48885.018.15 
- Public TitleThe effect of bezafibrate on itch in liver disease
- Scientific TitleThe effect of bezafibrate on cholestatic pruritus
- ACRONYMFITCH
- hypothesisBezafibrate alleviates itch complaints in patients with cholestatic liver disease.
- Healt Condition(s) or Problem(s) studiedPrimary and secondary sclerosing cholangitis, Primary biliary cholangitis
- 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).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate1-apr-2017
- Target number of participants84
- Interventionsbezafibrate 400mg once daily for 3 weeks
- Primary outcomeItch intensity score on a visual analogue scale (VAS)
- Secondary outcome-5D itch score: questionnaire for the evaluation of the 5 dimensions of itch and itís 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.
- Timepointsstart of treatment (day 0); end of treatment (day 21); follow-up (day 35)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Ruth Bolier
- CONTACT for SCIENTIFIC QUERIESDrs. Ruth Bolier
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Dutch Society of Gastroenterology (Nederlandse Vereniging voor Gastroenterologie (NVGE)), Dr. Falk Pharma, AMC Foundation
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD3-aug-2015 - 18-nov-2015


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