Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis

Phase 2 Completed 159 enrolled Dr. Falk Pharma GmbH

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start: 2012-12
Primary completion: 2015-10
Completion: 2015-12

Outcome

Met primary endpoint

paper p=0.029, p=0.003, and p<0.0001 when compared to placebo PMID 28529147 ↗

paper norUDCA significantly reduced ALP values dose-dependently in all treatment arms. PMID 28529147 ↗

Publications

Fickert P, Hirschfield GM, Denk G, Marschall HU, Altorjay I, Farkkila M, Schramm C, Spengler U, Chapman R, Bergquist A, Schrumpf E, Nevens F, Trivedi P, Reiter FP, Tornai I, Halilbasic E, Greinwald R, Prols M, Manns MP, Trauner M; European PSC norUDCA Study Group. norUrsodeoxycholic acid improves cholestasis in primary sclerosing cholangitis. J Hepatol. 2017 Sep;67(3):549-558. doi: 10.1016/j.jhep.2017.05.009. Epub 2017 May 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	norUDCA	Unknown	500 mg	Oral
Subject	norUDCA	Unknown	1000 mg	Oral
Subject	norUDCA	Unknown	1500 mg	Oral