|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
2 August 2021 |
|
Main ID: |
NCT04138927 |
|
Date of registration:
|
23/10/2019 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
|
|
Scientific title:
|
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia |
|
Date of first enrolment:
|
October 30, 2019 |
|
Target sample size:
|
90 |
|
Recruitment status: |
Enrolling by invitation |
|
URL:
|
https://clinicaltrials.gov/show/NCT04138927 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Australia
|
Austria
|
Belarus
|
Belgium
|
Bulgaria
|
Czechia
|
France
|
Georgia
|
|
Germany
|
Italy
|
Netherlands
|
Norway
|
Russian Federation
|
Serbia
|
Spain
|
Ukraine
|
|
United Kingdom
|
United States
| | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Subject must be willing and able to give written informed consent by signing an IRB
approved Informed Consent Form prior to undergoing any study-specific procedures.
2. Subject must have completed all 24 weeks of participation in the study C-935788-057.
Exclusion Criteria:
1. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.
Age minimum:
18 Years
Age maximum:
100 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Warm Antibody Autoimmune Hemolytic Anemia
|
|
Intervention(s)
|
|
Drug: Fostamatinib disodium
|
|
Primary Outcome(s)
|
|
Adverse Events
[Time Frame: 104 weeks]
|
|
Blood Pressure
[Time Frame: 104 weeks]
|
|
Absolute Neutrophil Count (ANC)
[Time Frame: 104 weeks]
|
|
Secondary Outcome(s)
|
|
Achievement of Durable Hemoglobin Response
[Time Frame: 24 weeks]
|
|
Corticosteroid dose
[Time Frame: During the Intervention period up to 104 weeks]
|
|
Total Duration of Response
[Time Frame: During the Intervention period up to 104 weeks]
|
|
Secondary ID(s)
|
|
C-935788-058
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|