An Open Label Extension Study of Voxelotor (GBT440) Administered Orally to Participants with Sickle Cell Disease Who Have Participated in Voxelotor Clinical Trials

Global Blood Therapeutics, Inc.0 个研究点目标入组 183 人开始时间: 2018年1月16日最近更新: 2024年3月18日

适应症

试验速览

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•1. Male or female study participants with SCD who participated and received study treatment in Study GBT440-031.
•Note: Participants in GBT440-031 who discontinued study drug due to an AE, but who remained on study may be eligible for treatment in this study provided the AE does not pose a risk for treatment with Voxelotor.
•2. Females of child-bearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1.
•3. Female participants of child-bearing potential must use highly effective methods of contraception to 30 days after the last dose of study drug. Male participants must continue to use barrier methods of contraception to 30 days after the last dose of study
•4. Participant has provided written informed consent or assent (the ICF must be reviewed and signed by each participant; in the case of pediatric participants, both the consent of the participant’s legal representative or legal guardian, and the participant’s assent must be obtained).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 28
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 155
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Female who is breast-feeding or pregnant.
•2. Participant withdrew consent from Study GBT440-031.
•3. Participant was lost to follow-up from Study GBT440-031.
•4. Participant requiring chronic dialysis.
•5. Any medical, psychological, safety, or behavioral conditions, which, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.

发起方