Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH)

• Status: Not yet recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2 study. All patients will receive prednisolone and AZA as standard of care (SOC) during the study. At the end of the study, all data collected will be analyzed the efficacy and safety of JKB-122 on SOC reduction and inflammation improvement in Autoimmune Hepatitis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TaiwanJ Pharmaceuticals Co., Ltd

Criteria

Inclusion Criteria:

1. Male or female, 18 to 65 years old.

2. If female of childbearing potential, must not be pregnant or breastfeeding and either postmenopausal (no menses for previous 12 months) or using an effective method of birth control.

3. Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria.

4. New diagnosis of AIH that requires treatment according to the current EASL guidelines.

5. Has elevated liver test results (ALT) at least 5x ULN at screening.

6. Is capable of understanding and signing the informed consent document.

Exclusion Criteria:

1. Overlap syndrome with Primary Sclerosing Cholangitis (PSC) or Primary Biliary Cholangitis (PBC)

2. Has cirrhosis on liver biopsy, or Child-Pugh score greater than 6 at screening.

3. Has human immunodeficiency virus (HIV) or is hepatitis B virus or HCV positive.

4. Has history of alcohol intake > 25 g/day within the past six months.

5. Severe anemia, leukopenia , or thrombocytopenia.

6. Known intolerances to prednisolone or azathioprine.

7. Current treatment with prednisone/prednisolone and/or immunosuppressive medication for an indication other than autoimmune hepatitis

8. Has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold

9. Has unstable and uncontrollable hypertension (>180/110 mmHg)

10. Has current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully.

11. Has any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator.