Warm Antibody Autoimmune Hemolytic Anemia
Conditions
Keywords
Warm antibody autoimmune hemolytic anemia (AIHA)
Brief summary
The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).
Interventions
DRUGFostamatinib 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.
Sponsors
Rigel Pharmaceuticals
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin response | by Week 24 | Hemoglobin level of \> 10 g/dL and 2 g/dL higher than the baseline hemoglobin |
Countries
Canada, United States
Outcome results
None listed