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

NCT05866809 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-07-27

No results posted yet for this study

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.

Conditions

  • Primary Sclerosing Cholangitis

Interventions

DRUG

HK-660S

Administered orally

DRUG

Placebo

Administered orally

Sponsors & Collaborators

  • CuromeBiosciences

    lead INDUSTRY

Principal Investigators

  • Do-hyun Park · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2023-06-23
Completion
2023-07-24

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05866809 on ClinicalTrials.gov