Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis

Summary

The objective of this study is to evaluate the improvement of bile duct strictures following the administration of HK-660S in patients with Primary Sclerosing Cholangitis(PSC). Percentage of subjects who show improvement of severity of PSC as assessed by Magnetic Resonance Cholangiopancreatography(MRCP) at Week 12 from baseline, with improvement defined as a decrease of -1 or more in the MRCP and change of alkaline phosphatase(ALP) level will be assessed at Week 12 from baseline.

Timeline

Start

2021-10-28

Primary completion

2023-06-23

Completion

2023-07-24

Drugs

Indications