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CompletedNCT05476900Updated Mar 24, 2025

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

A Phase 2 interventional study of HR19042 Capsules in Autoimmune Hepatitis, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Autoimmune Hepatitis
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 69 is below the median of 100 across 1,887 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    12 mg HR19042 Capsules QD

    Drug: HR19042 Capsules

  • Experimental
    4 mg HR19042 Capsules TID

    Drug: HR19042 Capsules

  • Experimental
    8 mg HR19042 Capsules QD

    Drug: HR19042 Capsules

Interventions

  • DrugHR19042 Capsules

    HR19042 Capsules

06

What researchers measure

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

07

Study locations

1 site
  • Shanghai Jiao Tong University School of Medicine, Renji Hospital
    Shanghai, Shanghai 200120, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05476900
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Jul 27, 2022
Start date
Oct 6, 2022
Primary completion
Mar 14, 2025
Completion
Mar 14, 2025
Last update
Mar 24, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Jiangsu HengRui Medicine Co., Ltd.

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