Autoimmune Hepatitis
Conditions
Interventions
investigational material(s)
Generic name etc : VAY736
Dosage and Administration : VAY736 Dose 1/Dose 2/Dose 3
control material(s)
Generic name etc : Placebo
Dosage and Administration: Placebo control
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * AIH diagnosed per International Autoimmune Hepatitis Group * Liver biopsy with Ishak modified HAI indicating active AIH * Incomplete response to OR intolerance of standard therapy (per AASLD)
Exclusion criteria
Exclusion criteria: * Prior use of any B-cell depleting therapy * Required regular use of medications with known hepatotoxicity * Decompensated cirrhosis * Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC) * Drug related AIH at screening or a history of drug related AIH * History of drug abuse or unhealthy alcohol use * History of malignancy of any organ system * Pregnant or nursing (lactating) women Other protocol defined inclusion/exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy ALT normalization [ Time Frame: Week 24 ] Difference in ALT normalization | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy ALT normalization by dose [ Time Frame: Week 24 ] VAY736 dose-response | — |
Countries
Europe, Japan, North America
Contacts
Public ContactHiroyuki Yamada
Novartis Pharma K. K.
Outcome results
None listed