EUCTR2019-003144-76-GB进行中（未招募）1 期
An Open-Label Extension Study of Voxelotor Administered Orally to Pediatric Participants with Sickle Cell Disease Who Have Participated in Voxelotor Clinical Trials
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participants who meet all of the following criteria will be eligible for study enrollment:
- •1. Male or female participant with SCD, aged = 4 to = 18 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 participant of childbearing potential is required to have a negative urine pregnancy test prior to 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 participant of childbearing potential must use highly effective methods of contraception until 30 days after the last dose of study drug. If sexually active, male participant 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)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:
- •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
研究者
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