NCT05190523CompletedPhase 2
Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis
Source: ClinicalTrials.gov · Last updated 27 Sept 2024
Brief summary (registry, in English)
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 matched placebo in subjects with primary biliary cholangitis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 98 (actual)
- First submitted
- 13 Dec 2021
- Start date
- 6 Apr 2022
- Primary completion date
- 13 Mar 2024
- Lead sponsor
- Gannex Pharma Co., Ltd.
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT05190523
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 98
- From 6 Apr 2022 to the primary completion date, 13 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History or presence of other concomitant liver diseases
Lab values
- ALT or AST \> 5× ULN; ALP \>10× ULN
Other
- Child-Pugh grade B or C
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.