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

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Autoimmune Hepatitis

Treatments: Drug: HR19042 Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT05476900

HR19042-202

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years old≤Female or male patients≤70 years old；
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

1. Patients with other chronic liver diseases；
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 3 patient groups

12 mg HR19042 Capsules QD

Experimental group

Treatment:

Drug: HR19042 Capsules

4 mg HR19042 Capsules TID

Experimental group

Treatment:

Drug: HR19042 Capsules

8 mg HR19042 Capsules QD

Experimental group

Treatment:

Drug: HR19042 Capsules