CompletedPhase 2

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

China69 participantsStarted 2022-10-06

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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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；

What they're measuring

Percentage of biochemical response after 12 weeks of treatment.

Timeframe: 12 weeks

Trial details

NCT IDNCT05476900

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-14

View on ClinicalTrials.gov More Autoimmune Hepatitis trials