NL-OMON52948招募中3 期
An Open Label Extension Study of Voxelotor (GBT440) Administered Orally to Participants with Sickle Cell Disease Who Have Participated in Voxelotor Clinical Trials - GBT440-034, GBT-OLE
Global Blood Therapeutics0 个研究点目标入组 19 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •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 drug.
- •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).
排除标准
- •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.
研究者
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终止
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