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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)

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)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0006590
Enrollment
25
Registered
2021-09-17
Start date
2021-11-26
Completion date
Unknown
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of HK-660S Administered for 12 Weeks in Patients With Primary Sc

Sponsors

Curome Biosciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of Primary Sclerosing Cholangitis(PSC)

Exclusion criteria

Exclusion criteria: - Clinically significant acute or chronic liver disease of an etiology other than PSC - Secondary or IgG4 related sclerosing cholangitis

Design outcomes

Primary

MeasureTime frame
The mean and percent change in MRCP Score, ALP—

Secondary

MeasureTime frame
The mean and percent change in ALT, AST,GGT, bilirubin—

Countries

Korea, Republic of

Contacts

Public ContactEun Ha Kim

Asan Medical Center

sp98rn@naver.com+82-2-2045-3825

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 5, 2026