norUDCA phase3 trial on-going in Europe

General
1

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).

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2■■■■67-19
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

2

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

3

Same info now available via easier to read US website (FDA):

Actual Study Start Date: February 8, 2018
Estimated Primary Completion Date: April 2021
Estimated Study Completion Date: December 2023