Efficacy and Safety of HK-660S in the Treatment of Primary Sclerosing Cholangitis
The cause of PSC is unknown.To date, there is no treatment besides liver transplantation proven to improve PSC prognosis. However, there is a clear medical unmet need yet for patients with PSC, due to risks and complications of liver transplantation. This is a two-part, Phase 2b, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of HK-660S in patients with PSC. The primary objective is to evaluate the effects of HK-660S on serum ALP improvement (reduction of 20% or more) over 12 weeks of treatment in patients with PSC.
Male or female subjects aged ≥ 18 years. [+6]
Subjects with an average alcohol intake of more than 20g per day within 2 years... [+23]