A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
- Conditions
- 10003816Warm antibody autoimmune hemolytic anemia10018849
- Registration Number
- NL-OMON55183
- Lead Sponsor
- Rigel Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
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.
3. Female subjects must be either post-menopausal for at least 1 year or
surgically sterile; or, if of childbearing potential, must not be pregnant or
lactating and must agree to use a highly effective method of birth control
throughout the duration of the trial and for 30 days following the last dose.
Acceptable methods of birth control are defined as: hormonal contraception
(pill, injection or implant) used consistently for at least 30 days prior to
baseline an intrauterine device (IUD), or intrauterine hormone-releasing system
(IUS), or true abstinence (i.e. abstinence is in line with the preferred and
usual lifestyle of the subject).
4. In the investigator*s opinion, the subject has the ability to understand the
nature of the study and any hazards of participation and to communicate
satisfactorily with the investigator.
1. Any subject who discontinued participation in Study C-935788-057 prior to
Week 24.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method