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

Overview

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

Full Title of Study: “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 Anemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

Interventions

  • Drug: Fostamatinib 150 mg bid
    • Fostamatinib 150 mg bid. The dose of Fostamatinib may be reduced at any time to as low as 100 mg PO once daily (qd) if dose limiting adverse events are observed.

Arms, Groups and Cohorts

  • Experimental: Fostamatinib 150 mg
    • Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Hemoglobin response
    • Time Frame: by Week 24
    • Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin

Participating in This Clinical Trial

Inclusion Criteria

Subject must have had a diagnosis of primary or secondary warm antibody AIHA.

  • Must have failed at least 1 prior treatment regimen for AIHA. Exclusion Criteria:
  • Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria. – Subject with a platelet count of < 30,000/μL. – Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy. – Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Rigel Pharmaceuticals
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Rigel Pharmaceuticals, Study Director, Rigel Pharmaceuticals, Inc.

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