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

Primary Purpose

Autoimmune Hepatitis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HR19042 Capsules
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Hepatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Jiao Tong University School of Medicine, Renji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

12 mg HR19042 Capsules QD

4 mg HR19042 Capsules TID

8 mg HR19042 Capsules QD

Arm Description

Outcomes

Primary Outcome Measures

Percentage of biochemical response after 12 weeks of treatment.

Secondary Outcome Measures

Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 12 weeks of treatment.
Percentage of partial response after 12 weeks of treatment
Percentage of biochemical response after 24 weeks of treatment.
Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 24 weeks of treatment.
Percentage of partial response after 24 weeks of treatment.
Change from baseline in serum ALT levels.
Change from baseline in serum AST levels.

Full Information

First Posted
July 25, 2022
Last Updated
August 17, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05476900
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized, open-label, multicenter, parallel groups, Phase II clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
12 mg HR19042 Capsules QD
Arm Type
Experimental
Arm Title
4 mg HR19042 Capsules TID
Arm Type
Experimental
Arm Title
8 mg HR19042 Capsules QD
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HR19042 Capsules
Intervention Description
HR19042 Capsules
Primary Outcome Measure Information:
Title
Percentage of biochemical response after 12 weeks of treatment.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 12 weeks of treatment.
Time Frame
12 weeks
Title
Percentage of partial response after 12 weeks of treatment
Time Frame
12 weeks
Title
Percentage of biochemical response after 24 weeks of treatment.
Time Frame
24 weeks
Title
Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 24 weeks of treatment.
Time Frame
24 weeks
Title
Percentage of partial response after 24 weeks of treatment.
Time Frame
24 weeks
Title
Change from baseline in serum ALT levels.
Time Frame
2, 4, 8, 12, 18, 24 weeks
Title
Change from baseline in serum AST levels.
Time Frame
2, 4, 8, 12, 18, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guangchao Dong
Phone
+0518-82342973
Email
Guangchao.dong.gd1@hengrui.com
Facility Information:
Facility Name
Shanghai Jiao Tong University School of Medicine, Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiong Ma

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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