Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis
Lead Sponsor:
Gannex Pharma Co., Ltd.
Conditions:
Primary Biliary Cholangitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is a phase II, multicenter, randomized, double-blind, placebo-controlled, seamless adaptive design clinical study, aiming to evaluate the safety and effectiveness of three doses of ASC42 ma...
Eligibility Criteria
Inclusion
- Age ≥ 18 and ≤75 years old at screening.
- Definite or probable PBC diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors:
- Biochemical evidence of cholestasis based on ALP elevation.
- Presence of AMA, or other PBC-specific autoantibodies, including sp100 or gp210, if AMA is negative.
- Liver biopsy consistent with PBC.
- Screening ALP ≥ 1.67× ULN
- Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0.
Exclusion
- ALT or AST \> 5× ULN; ALP \>10× ULN
- History or presence of other concomitant liver diseases
- Child-Pugh grade B or C
Key Trial Info
Start Date :
April 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2024
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05190523
Start Date
April 6 2022
End Date
March 13 2024
Last Update
September 27 2024
Active Locations (1)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100071