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

March 20, 2025 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Shanghai Jiao Tong University School of Medicine, Renji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 12 mg HR19042 Capsules QD
Drug: HR19042 Capsules
HR19042 Capsules
Experimental: 4 mg HR19042 Capsules TID
Drug: HR19042 Capsules
HR19042 Capsules
Experimental: 8 mg HR19042 Capsules QD
Drug: HR19042 Capsules
HR19042 Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of biochemical response after 12 weeks of treatment.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 12 weeks of treatment.
Time Frame: 12 weeks
12 weeks
Percentage of partial response after 12 weeks of treatment
Time Frame: 12 weeks
12 weeks
Percentage of biochemical response after 24 weeks of treatment.
Time Frame: 24 weeks
24 weeks
Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 24 weeks of treatment.
Time Frame: 24 weeks
24 weeks
Percentage of partial response after 24 weeks of treatment.
Time Frame: 24 weeks
24 weeks
Change from baseline in serum ALT levels.
Time Frame: 2, 4, 8, 12, 18, 24 weeks
2, 4, 8, 12, 18, 24 weeks
Change from baseline in serum AST levels.
Time Frame: 2, 4, 8, 12, 18, 24 weeks
2, 4, 8, 12, 18, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2022

Primary Completion (Actual)

March 14, 2025

Study Completion (Actual)

March 14, 2025

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR19042-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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