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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
HR19042 Capsules
Shanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China
Percentage of biochemical response after 12 weeks of treatment.
Time frame: 12 weeks
Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 12 weeks of treatment.
Time frame: 12 weeks
Percentage of partial response after 12 weeks of treatment
Time frame: 12 weeks
Percentage of biochemical response after 24 weeks of treatment.
Time frame: 24 weeks
Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 24 weeks of treatment.
Time frame: 24 weeks
Percentage of partial response after 24 weeks of treatment.
Time frame: 24 weeks
Change from baseline in serum ALT levels.
Time frame: 2, 4, 8, 12, 18, 24 weeks
Change from baseline in serum AST levels.
Time frame: 2, 4, 8, 12, 18, 24 weeks
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