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

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Brief Title

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

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.

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percentage of biochemical response after 12 weeks of treatment.

Secondary Outcome

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

Condition

Autoimmune Hepatitis

Intervention

HR19042 Capsules

Study Arms / Comparison Groups

 12 mg HR19042 Capsules QD
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

81

Start Date

August 30, 2022

Completion Date

March 30, 2024

Primary Completion Date

December 30, 2023

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, +0518-82342973, [email protected]



Administrative Informations


NCT ID

NCT05476900

Organization ID

HR19042-202


Responsible Party

Sponsor

Study Sponsor

Jiangsu HengRui Medicine Co., Ltd.


Study Sponsor

, , 


Verification Date

July 2022