Phase 3
Completed N=90
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA
Warm Antibody Autoimmune Hemolytic Anemia
Source: ClinicalTrials.gov NCT03764618 ↗
Enrolled (actual)
90
Serious AEs
35.6%
Results posted
May 2023
Primary outcomePrimary: Durable Hemoglobin Response — 16; 12 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Durable Hemoglobin Response |
16; 12 | — |
| SECONDARY A Hemoglobin Response by Week 24 |
21; 16 | — |
| SECONDARY Change From Baseline in Hemoglobin Level of 2 g/dL or Greater |
22; 16 | — |
| SECONDARY Change in Hemoglobin From Baseline to End of Treatment |
1.99; 1.99 | — |
| SECONDARY Use of Rescue Antibody Autoimmune Hemolytic Anemia (AIHA) Regimens Use After Week 4 |
18; 18 | — |
| SECONDARY Change in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) |
4.1; 2.2 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must have a diagnosis of primary or secondary warm Antibody Autoimmune Hemolytic Anemia (wAIHA) as documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA.
- Have failed or not tolerated at least one prior wAIHA treatment regimen, including steroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, MMF, danazol, vincristine, ESA or splenectomy (folate, iron or other supplements do not fulfill this criterion).
- Have haptoglobin ULN or lactate dehydrogenase (LDH) >ULN.
- At screening, subject's hemoglobin level must be ≤9 g/dL OR if hemoglobin value >9 g/dL and 1.5 x ULN.
- Has documented active hepatitis B or hepatitis C infection or HIV infection.
Data sourced from ClinicalTrials.gov (NCT03764618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.