Last updated on June 2019

ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Autoimmune hepatitis
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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