A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis.
A Randomized, Open-label, Multicenter, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis.
1 other identifier
interventional
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2022
CompletedFirst Posted
Study publicly available on registry
July 27, 2022
CompletedStudy Start
First participant enrolled
October 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2025
CompletedMarch 24, 2025
March 1, 2025
2.4 years
July 25, 2022
March 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of biochemical response after 12 weeks of treatment.
12 weeks
Secondary Outcomes (7)
Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 12 weeks of treatment.
12 weeks
Percentage of partial response after 12 weeks of treatment
12 weeks
Percentage of biochemical response after 24 weeks of treatment.
24 weeks
Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 24 weeks of treatment.
24 weeks
Percentage of partial response after 24 weeks of treatment.
24 weeks
- +2 more secondary outcomes
Study Arms (3)
12 mg HR19042 Capsules QD
EXPERIMENTAL4 mg HR19042 Capsules TID
EXPERIMENTAL8 mg HR19042 Capsules QD
EXPERIMENTALInterventions
HR19042 Capsules
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200120, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2022
First Posted
July 27, 2022
Study Start
October 6, 2022
Primary Completion
March 14, 2025
Study Completion
March 14, 2025
Last Updated
March 24, 2025
Record last verified: 2025-03