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

Autoimmune Hepatitis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05476900
• Other study ID #: HR19042-202
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune

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