A Phase 3 interventional study of Bezafibrate and Placebo in Primary Biliary Cholangitis, Primary Sclerosing Cholangitis and Secondary Sclerosing Cholangitis, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Status unknown at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Phase 3, Interventional, and Treatment
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.
228 studies on the registry are indexed under Cholangitis; 32 are open to participants now.
This study's planned enrollment of 84 is above the median of 56 across 150 interventional studies indexed under Cholangitis.
Browse Cholangitis studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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);
Bezalip retard 400mg tablet
Drug: Bezafibrate
Placebo 400mg tablet
Drug: Placebo
bezafibrate 400mg per day
Also known as: bezalip
placebo 400mg per day
Proportion of patients with a reduction in itch intensity of 50% or more
Time frame: 3 weeks
Serum liver tests
Time frame: 3 weeks
Serum creatinine
Time frame: 3 weeks
Serum cholesterol
Time frame: 3 weeks
Serum autotaxin activity
Time frame: 3 weeks
Serum creatinin kinase
Time frame: 3 weeks
Plan to share: Undecided
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)