Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05476900
Other study ID # HR19042-202
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 6, 2022
Est. completion date March 30, 2024

Study information

Verified date August 2023
Source Jiangsu HengRui Medicine Co., Ltd.
Contact Guangchao Dong
Phone +0518-82342973
Email Guangchao.dong.gd1@hengrui.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 81
Est. completion date March 30, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Intervention

Drug:
HR19042 Capsules
HR19042 Capsules

Locations

Country Name City State
China Shanghai Jiao Tong University School of Medicine, Renji Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of biochemical response after 12 weeks of treatment. 12 weeks
Secondary Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 12 weeks of treatment. 12 weeks
Secondary Percentage of partial response after 12 weeks of treatment 12 weeks
Secondary Percentage of biochemical response after 24 weeks of treatment. 24 weeks
Secondary Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 24 weeks of treatment. 24 weeks
Secondary Percentage of partial response after 24 weeks of treatment. 24 weeks
Secondary Change from baseline in serum ALT levels. 2, 4, 8, 12, 18, 24 weeks
Secondary Change from baseline in serum AST levels. 2, 4, 8, 12, 18, 24 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06020976 - Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT06250309 - Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients N/A
Recruiting NCT01661842 - Umbilical Cord Mesenchymal Stem Cells for Patients With Autoimmune Hepatitis Phase 1/Phase 2
Terminated NCT04339621 - AIH Risk Stratification With Multiparametric MRI
Not yet recruiting NCT04371718 - Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH) Phase 2
Completed NCT02239562 - sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS Phase 1
Recruiting NCT05569759 - A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA) Phase 2
Completed NCT02463331 - Association of Chloroquine and Prednisone as an Alternative Treatment for Autoimmune Hepatitis Phase 4
Not yet recruiting NCT06356506 - A Study on Factors of Biochemical Response in Autoimmune Hepatitis
Terminated NCT04203875 - Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis Phase 1
Recruiting NCT06078098 - Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage
Completed NCT00838214 - Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis Phase 2/Phase 3
Recruiting NCT05810480 - PredIcting sterOid depeNdEnt livEr injuRy With Polyreactive Immunoglobulin G
Recruiting NCT03743272 - Repeatability and Reproducibility of Multiparametric MRI
Completed NCT03979053 - Quantitative Magnetic Resonance Imaging to Aid Clinical Decision Making in Autoimmune Hepatitis.
Not yet recruiting NCT04902807 - Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation
Recruiting NCT04933292 - A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome Phase 4
Not yet recruiting NCT06455280 - SIPLIZUMAB in AILD and LT Phase 1
Completed NCT05532345 - Discrimination of DILI and AIH by Artificial Intelligence