A Study to Evaluate the Efficacy and Safety of HR19042 Ca... | NCT05476900

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

NCT05476900

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Status

Completed

Last Update Posted

Mar 24, 2025Actual

Enrollment

69Actual

Phase

Phase 2

Conditions

Autoimmune Hepatitis

Interventions

HR19042 Capsules

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 6, 2022Actual

Primary Completion Date

Mar 14, 2025Actual

Completion Date

Mar 14, 2025Actual

First Submitted Date

Jul 25, 2022

First Submission Date that Met QC Criteria

Jul 25, 2022

First Posted Date

Jul 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2025

Last Update Posted Date

Mar 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
12 mg HR19042 Capsules QD	Experimental	Drug: HR19042 Capsules
4 mg HR19042 Capsules TID	Experimental	Drug: HR19042 Capsules
8 mg HR19042 Capsules QD	Experimental	Drug: HR19042 Capsules

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HR19042 Capsules	Drug	HR19042 Capsules	12 mg HR19042 Capsules QD 4 mg HR19042 Capsules TID 8 mg HR19042 Capsules QD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of biochemical response after 12 weeks of treatment.		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Jiao Tong University School of Medicine, Renji Hospital		Shanghai	Shanghai Municipality	200120	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019693	Hepatitis, Autoimmune

Ancestor Terms

ID	Term
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided