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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.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02612558
Date of registration: 19/11/2015
Prospective Registration: Yes
Primary sponsor: Rigel Pharmaceuticals
Public title: A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA) SOAR
Scientific 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
Date of first enrolment: July 2016
Target sample size: 37
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02612558
Study type:  Interventional
Study design:  Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Canada United States
Contacts
Name:     Rigel Pharmaceuticals
Address: 
Telephone:
Email:
Affiliation:  Rigel Pharmaceuticals, Inc.
Key inclusion & exclusion 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/┬ÁL.

- 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
Health Condition(s) or Problem(s) studied
Warm Antibody Autoimmune Hemolytic Anemia
Intervention(s)
Drug: Fostamatinib 150 mg bid
Primary Outcome(s)
Hemoglobin response [Time Frame: by Week 24]
Secondary Outcome(s)
Secondary ID(s)
C-935788-053
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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