A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis.
NCT ID: NCT05476900
Last Updated: 2025-03-24
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
69 participants
INTERVENTIONAL
2022-10-06
2025-03-14
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
NONE
Study Groups
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12 mg HR19042 Capsules QD
HR19042 Capsules
HR19042 Capsules
4 mg HR19042 Capsules TID
HR19042 Capsules
HR19042 Capsules
8 mg HR19042 Capsules QD
HR19042 Capsules
HR19042 Capsules
Interventions
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HR19042 Capsules
HR19042 Capsules
Eligibility Criteria
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Inclusion Criteria
2. Clinical-confirmed autoimmune hepatitis；
3. Biopsy-confirmed autoimmune hepatitis；
4. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 × upper limit of normal (ULN)；
5. Willing and able to give informed consent and follow the protocols during the trial.
Exclusion Criteria
2. Patients with liver cirrhosis；
3. Patients with hepatic encephalopathy；
4. Positive results in HIV-Ab/TP-Ab/hepatitis virus tests
5. Severe chronic or active infection requiring systemic anti-infective therapy within 14 days before screening；
6. Patients with severe cardiovascular diseases；
7. Patients with malignancy within the past 5 years；
8. Patients received organ transplantation；
9. Patients treated with any systemic corticosteroids within 3 months before screening；
10. Patients treated with any systemic immunosuppressive drugs within the 6 months before screening.
18 Years
70 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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HR19042-202
Identifier Type: -
Identifier Source: org_study_id
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