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).
Brief Title
A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)
Completion Date
Completion Date Type
Actual
Conditions
Warm Antibody Autoimmune Hemolytic Anemia
Eligibility Criteria
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.
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.
Inclusion Criteria
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.
Subject must have had a diagnosis of primary or secondary warm antibody AIHA.
- Must have failed at least 1 prior treatment regimen for AIHA.
Gender
All
Gender Based
false
Keywords
Warm antibody autoimmune hemolytic anemia (AIHA)
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02612558
Org Class
Industry
Org Full Name
Rigel Pharmaceuticals
Org Study Id
C-935788-053
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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 Anemia
Primary Outcomes
Outcome Description
Hemoglobin level of \> 10 g/dL and 2 g/dL higher than the baseline hemoglobin
Outcome Measure
Hemoglobin response
Outcome Time Frame
by Week 24
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Irina Murakhovskaya
Investigator Email
imurakho@montefiore.org
Investigator Phone
IMURAKHO