Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis
NCT ID: NCT05190523
Last Updated: 2024-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
98 participants
INTERVENTIONAL
2022-04-06
2024-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ASC42 tablets of 5mg
ASC42 tablets 5mg for 12 weeks
ASC42 5 mg
5 mg of ASC42 tablets orally once daily for 12 weeks.
ASC42 tablets of 10mg
ASC42 tablets 10mg for 12 weeks
ASC42 10 mg
2 x 5 mg of ASC42 tablets orally once daily for 12 weeks.
ASC42 tablets of 15mg
ASC42 tablets 15mg for 12 weeks
ASC42 15 mg
15 mg of ASC42 tablets orally once daily for 12 weeks.
Placebo
Placebo for 12 weeks
Placebo
Placebo tablets orally once daily for 12 weeks.
Interventions
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ASC42 5 mg
5 mg of ASC42 tablets orally once daily for 12 weeks.
ASC42 10 mg
2 x 5 mg of ASC42 tablets orally once daily for 12 weeks.
ASC42 15 mg
15 mg of ASC42 tablets orally once daily for 12 weeks.
Placebo
Placebo tablets orally once daily for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Definite or probable PBC diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors:
1. Biochemical evidence of cholestasis based on ALP elevation.
2. Presence of AMA, or other PBC-specific autoantibodies, including sp100 or gp210, if AMA is negative.
3. 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 Criteria
* History or presence of other concomitant liver diseases
* Child-Pugh grade B or C
18 Years
75 Years
ALL
No
Sponsors
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Gannex Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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ASC42-202
Identifier Type: -
Identifier Source: org_study_id
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