A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis.
Phase 2
Completed
- Conditions
- Autoimmune Hepatitis
- Interventions
- Drug: HR19042 Capsules
- Registration Number
- NCT05476900
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
This study will evaluate the efficacy and safety of HR19042 capsules for the treatment of autoimmune hepatitis. It will also explore the optimal frequency and dosage of HR19042 capsules administration for the treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
Inclusion Criteria
- 18 years old≤Female or male patients≤70 years old；
- Clinical-confirmed autoimmune hepatitis；
- Biopsy-confirmed autoimmune hepatitis；
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 × upper limit of normal (ULN)；
- Willing and able to give informed consent and follow the protocols during the trial.
Exclusion Criteria
- Patients with other chronic liver diseases；
- Patients with liver cirrhosis；
- Patients with hepatic encephalopathy；
- Positive results in HIV-Ab/TP-Ab/hepatitis virus tests
- Severe chronic or active infection requiring systemic anti-infective therapy within 14 days before screening；
- Patients with severe cardiovascular diseases；
- Patients with malignancy within the past 5 years；
- Patients received organ transplantation；
- Patients treated with any systemic corticosteroids within 3 months before screening；
- Patients treated with any systemic immunosuppressive drugs within the 6 months before screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 8 mg HR19042 Capsules QD HR19042 Capsules - 4 mg HR19042 Capsules TID HR19042 Capsules - 12 mg HR19042 Capsules QD HR19042 Capsules -
- Primary Outcome Measures
Name Time Method Percentage of biochemical response after 12 weeks of treatment. 12 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in serum AST levels. 2, 4, 8, 12, 18, 24 weeks Percentage of biochemical response after 24 weeks of treatment. 24 weeks Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 24 weeks of treatment. 24 weeks Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 12 weeks of treatment. 12 weeks Percentage of partial response after 12 weeks of treatment 12 weeks Percentage of partial response after 24 weeks of treatment. 24 weeks Change from baseline in serum ALT levels. 2, 4, 8, 12, 18, 24 weeks
Trial Locations
- Locations (1)
Shanghai Jiao Tong University School of Medicine, Renji Hospital
🇨🇳Shanghai, Shanghai, China