A randomized, double-blind, placebo-controlled, parallel group, 12 weeks, therapeutic exploratory phase 2 clinical study to evaluate the safety and efficacy of HK-660S in patients with Primary Sclerosing Cholangitis(PSC)
Not Applicable
Completed
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0006590
- Lead Sponsor
- Curome Biosciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Confirmed diagnosis of Primary Sclerosing Cholangitis(PSC)
Exclusion Criteria
- Clinically significant acute or chronic liver disease of an etiology other than PSC
- Secondary or IgG4 related sclerosing cholangitis
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean and percent change in MRCP Score, ALP
- Secondary Outcome Measures
Name Time Method The mean and percent change in ALT, AST,GGT, bilirubin