Primary Sclerosing Cholangitis (PSC) - Online Support Group

norUDCA phase3 trial on-going in Europe


Pretty exciting news and worth a separate post. Possibly the first fully regulatory body compliant phase3 clinical trial for PSC for decades.

I think this phase3 trial was started last year and will take 6 years to complete. Anyway, for our European forum members this might be interesting option to explore immediately (i.e. participate in the trial).

Full Title: Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis

Trial protocol: DE (Ongoing) AT (Ongoing) HU (Ongoing) LT (Ongoing) FI (Ongoing) CZ () DK (Ongoing) NL () SE (Ongoing)
Trial Status: Ongoing
Date on which this record was first entered in the EudraCT database: 2017-06-19
E.8.9 Initial estimate of the duration of the trial
E.8.9.1 In the Member State concerned years 6

F.4 Planned number of subjects to be included
F.4.2.2 In the whole clinical trial 300


That is great news! This is norurso. I wish they can bring the study to the U.S. too!