Evaluation of the efficacy of different doses of nor UDCA vs. placebo for the treatment of Primary Sclerosing Cholangitis (PSC). Identification of optimal dose(s)for the treatment of PSC.
Double-blind, randomized, multi-center, placebo-controlled, comparative exploratory phase II-finding trial.The study will be conducted with four treatment groups in the form of a parallel-group comparison and will serve to compare oral treatment with either 500 mg/d, 1000 mg/d or 1500 mg/d norursodeoxycholic acid capsules vs. Placebo capsules for the treatment of PSC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
159
Prof. M. Trauner
Vienna, Austria
Prof. Michael Manns
Hanover, Germany
Kirsten Boberg
Oslo, Norway
Change in serum AP levels during treatment
Time frame: 12 weeks
Proportion of patients with at least 50% reduction in s-ALP
Time frame: 12 weeks
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