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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05476900

Enrollment

Registered

2022-07-27

Start date

2022-10-06

Completion date

2025-03-14

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Hepatitis

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.

Interventions

DRUGHR19042 Capsules

HR19042 Capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

A randomized, open-label, multicenter, parallel groups, Phase II clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
Percentage of biochemical response after 12 weeks of treatment.	12 weeks

Secondary

Measure	Time frame
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 biochemical response with the absence of glucocorticoid-related adverse events after 12 weeks of treatment.	12 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
Percentage of partial response after 24 weeks of treatment.	24 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026