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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05476900
Collaborator
(none)
81
Enrollment
3
Arms
19
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: HR19042 Capsules
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
81 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A randomized, open-label, multicenter, parallel groups, Phase II clinical trialA randomized, open-label, multicenter, parallel groups, Phase II clinical trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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.
Anticipated Study Start Date :
Aug 30, 2022
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

  2. Percentage of partial response after 12 weeks of treatment [12 weeks]

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

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

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

  6. Change from baseline in serum ALT levels. [2, 4, 8, 12, 18, 24 weeks]

  7. Change from baseline in serum AST levels. [2, 4, 8, 12, 18, 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
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:

  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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05476900
Other Study ID Numbers:
  • HR19042-202
First Posted:
Jul 27, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hepatitis A
Hepatitis
Hepatitis, Autoimmune

Study Results

No Results Posted as of Jul 27, 2022