A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA
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|ClinicalTrials.gov Identifier: NCT03764618|
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : August 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Warm Antibody Autoimmune Hemolytic Anemia||Drug: Fostamatinib disodium Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
Initial dose is 100 mg PO bid. At week 4 dose will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug in the opinion of the Investigator.
Drug: Fostamatinib disodium
Fostamatinib (100mg PO bid or 150 mg PO bid)
The dose may be reduced at any time to a dose as low as fostamatinib 100 mg PO qd or matching placebo if dose limiting adverse events are observed.
Placebo Comparator: Placebo
Initial dose is 100 mg PO bid. At week 4 dose will be increased to placebo 150 mg PO bid if subjects have adequately tolerated the study drug in the opinion of the Investigator.
- Durable Hemoglobin Response [ Time Frame: 24 Weeks ]The primary efficacy endpoint is the proportion of subjects who achieve a durable hemoglobin response.
- Subjects with a hemoglobin response by Week 24 [ Time Frame: 24 weeks ]Proportion of subjects with a hemoglobin response by Week 24
- Frequency of rescue AIHA regimens used [ Time Frame: 24 weeks ]Average frequency of rescue AIHA regimens used
- Hemoglobin assessments exhibiting a hemoglobin response [ Time Frame: 24 weeks ]Average number of hemoglobin assessments exhibiting a hemoglobin response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764618