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NCT Number: NCT05476900

A Study 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.

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Key information

Conditions

Autoimmune Hepatitis Autoimmune Diseases Digestive System Diseases Hepatitis Hepatitis, Autoimmune Hepatitis, Chronic Immune System Diseases Liver Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Jiao Tong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, 200120, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HR19042 Capsules

Drug

HR19042 Capsules

Primary outcomes

  1. Percentage of biochemical response after 12 weeks of treatment.

    Time frame: 12 weeks

Secondary outcomes

  1. Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 12 weeks of treatment.

    Time frame: 12 weeks

  2. Percentage of partial response after 12 weeks of treatment

    Time frame: 12 weeks

  3. Percentage of biochemical response after 24 weeks of treatment.

    Time frame: 24 weeks

  4. Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 24 weeks of treatment.

    Time frame: 24 weeks

  5. Percentage of partial response after 24 weeks of treatment.

    Time frame: 24 weeks

  6. Change from baseline in serum ALT levels.

    Time frame: 2, 4, 8, 12, 18, 24 weeks

  7. Change from baseline in serum AST levels.

    Time frame: 2, 4, 8, 12, 18, 24 weeks

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 27, 2022
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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