Summary

for people ages 18-75 (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

VAY736 dose testing; VAY736 efficacy and safety testing.

Official Title

A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of VAY736 in Autoimmune Hepatitis

Details

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.

Keywords

Autoimmune Hepatitis Type 1, Type 2, autoimmune hepatitis, AIH, Hepatitis A Hepatitis Hepatitis, Autoimmune VAY736

Eligibility

For people ages 18-75

Key Inclusion Criteria:

  1. AIH diagnosed per International Autoimmune Hepatitis Group
  2. Liver biopsy with Ishak modified HAI indicating active AIH
  3. Incomplete response to OR intolerance of standard therapy (per AASLD)

Key Exclusion Criteria

  1. Prior use of any B-cell depleting therapy
  2. Required regular use of medications with known hepatotoxicity
  3. Decompensated cirrhosis
  4. Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC).
  5. Drug related AIH at screening or a history of drug related AIH.
  6. History of drug abuse or unhealthy alcohol use
  7. History of malignancy of any organ system
  8. Pregnant or nursing (lactating) women

Locations

  • Novartis Investigative Site accepting new patients
    Sacramento California 95817 United States
  • Novartis Investigative Site accepting new patients
    Coronado California 92118 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
Links
Sign up for this study
ID
NCT03217422
Phase
Phase 2/3
Study Type
Interventional
Last Updated