LBCTR2020063513尚未招募3 期
An Open-Label Extension Study of Voxelotor Administered Orally to Participants with Sickle Cell Disease Who Have Participated in Voxelotor Clinical Trials
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 4 至 99（—）
- 性别
- All
入选标准
- •1. Male or female participant with SCD, aged = 4 years, who participated and received study drug in a GBT-sponsored voxelotor pediatric clinical study
- •Note: Participants 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. Female participants of childbearing potential are required to have a negative urine pregnancy test before dosing on Day 1.
- •Note: Female participants who become childbearing during the study must be willing to have a negative urine pregnancy test to remain in the study.
- •3. If sexually active, female participants of childbearing potential must use highly effective methods of contraception until 30 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 30 days after the last dose of study drug.
- •4. Participant has provided written assent (both the consent of the participant’s legal representative or legal guardian and the participant’s assent
- •[where applicable] must be obtained)
- •5. Subjects with abnormal TCD who have not completed Study GBT440-032 can participate in OLE study
排除标准
- •1. Female participant who is breastfeeding or pregnant
- •2. Participant withdrew consent from a GBT-sponsored voxelotor pediatric clinical study
- •3. Participant was lost to follow-up from a GBT-sponsored voxelotor pediatric clinical study
- •4. Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the investigator, may confound safety interpretation,
- •interfere with compliance, or preclude informed consent
- •5. Based on the most recent Oxbryta® US label (December 2021), co-administration with both moderate and strong CYP3A4 inducers should be avoided
研究者
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