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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 August 2021 |
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Main ID: |
NCT02612558 |
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Date of registration:
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19/11/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)
SOAR |
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Scientific title:
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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 |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02612558 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Rigel Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigel Pharmaceuticals, Inc. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Warm Antibody Autoimmune Hemolytic Anemia
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Intervention(s)
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Drug: Fostamatinib 150 mg bid
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Primary Outcome(s)
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Hemoglobin response
[Time Frame: by Week 24]
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Secondary ID(s)
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C-935788-053
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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