VAY736 dose testing; VAY736 efficacy and safety testing.
This is a randomized, placebo-controlled, double-blind dose range study in autoimmune hepatitis. The study population consists of female and male adult autoimmune hepatitis patients with incomplete response or intolerant to standard treatment of care. The diagnosis of autoimmune hepatitis has to fulfill the IAIHG criteria and must be confirmed by liver histology. Patients will be randomly assigned to different doses of VAY736 or placebo. The primary analysis is planned at 24 weeks. A subsequent study part will then test the efficacy and safety of VAY736 in a parallel group design. For this part of the trial a new group of autoimmune hepatitis patients will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
68
Southern California Research Center
ALT (Alanine aminotransferase) normalization
Difference in ALT normalization
Time frame: Week 24
ALT normalization by dose
VAY736 dose-response
Time frame: Week 24
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Coronado, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
University of California Davis Medical Center
Sacramento, California, United States
St. Lukes Advanced Liver Therapies
Houston, Texas, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
CABA, Argentina
Novartis Investigative Site
Ghent, Belgium
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
...and 18 more locations