A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis.

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-label, Multicenter, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis.

Conditions
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Autoimmune Hepatitis

Intervention / Treatment
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* Drug: HR19042 Capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, open-label, multicenter, parallel groups, Phase II clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 mg HR19042 Capsules QD<br> | Drug: HR19042 Capsules<br>* HR19042 Capsules<br>|
| Experimental: 4 mg HR19042 Capsules TID<br> | Drug: HR19042 Capsules<br>* HR19042 Capsules<br>|
| Experimental: 8 mg HR19042 Capsules QD<br> | Drug: HR19042 Capsules<br>* HR19042 Capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of biochemical response after 12 weeks of treatment. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 partial response after 24 weeks of treatment. |  | 24 weeks | 
| Change from baseline in serum ALT levels. |  | 2, 4, 8, 12, 18, 24 weeks | 
| Change from baseline in serum AST levels. |  | 2, 4, 8, 12, 18, 24 weeks |