A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura. - Rigel-049

INC Research0 个研究点目标入组 2 人开始时间: 待定最近更新: 2024年4月23日

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•1. Subject must be willing and able to give written informed consent by signing an IRB-approved Informed Consent Form prior to participating in any study-specific procedures.;2. Subjects must have completed the Week 24 evaluation of Study C-935788-047 or C-935788-048 or have discontinued early (starting at Week 12) due to lack of response. No more than 7 days may have elapsed between the last day of treatment on study C-935788-047 or C-935788-048 and the
•initial dosing (Day 1) in Study C-935788-049.;3. Male or female at least 18 years of age.;4. Females must be either post-menopausal for at least 1 year or surgically sterile; or if female of child-bearing potential, must not be pregnant or lactating and must agree to use an acceptable 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 toenrollment, intrauterine device (IUD), double-barrier (ie, condom and spermicide, or condom and diaphragm), or complete abstinence.;5. 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-935788-047 or C-935788-048 prior to Week 12 or for any reason other than lack of response. Exceptions may be considered on a case-by-case basis after consultation between the Investigator and Sponsor with the specific reason for the exception noted.;2. Subjects with poorly controlled hypertension during Study C-935788-047 or C-935788-048, defined as persistent or repeated systolic >= 140 mmHg, or diastolic >= 90 mmHg whether or not the subject is receiving anti-hypertensive treatment.;3. Subjects with the following laboratory abnormalities at the time of enrollment (Day 1): a leukocyte count < 2.000/µL, a neutrophil count of < 1,000/µL, lymphocyte count < 750/µL, Hgb < 10 g/dL, or transaminase levels (ALT, AST) > 1.5x ULN, bilirubin > 1.5x ULN, or estimated glomerular filtration rate (eGFR) < 30 mL/min.;4. Subjects who have a significant infection, an acute infection such as influenza, or known inflammatory process at the time of enrollment into this study.;5. Subjects who have received any blood or blood products within the 2 weeks prior to enrollment (IVIg or anti-D are allowed if used for rescue therapy).

发起方

INC Research