Clinical Trial: A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Ane

Brief Summary: The purpose of this study is to evaluate whether fostamatinib is safe and effective in treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).

Detailed Summary:
Sponsor: Rigel Pharmaceuticals

Current Primary Outcome: Hemoglobin response [ Time Frame: by Week 12 ]

Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Rigel Pharmaceuticals

Dates:
Date Received: November 19, 2015
Date Started: April 2016
Date Completion: September 2017
Last Updated: March 16, 2017
Last Verified: March 2017