LBCTR2019080216Other3 期
An Open Label Extension Study of GBT440 Administered Orally to Patients With Sickle Cell Disease Who Have Participated in GBT440 Clinical Trials
适应症
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 6
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
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 12 至 99（—）
- 性别
- All
入选标准
- •Male or female study participants with Sickle Cell Disease 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 GBT440.)
- •- Females of child-bearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1.
- •- 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.
- •- Participant has provided written informed consent or assent.
排除标准
- •- Female who is breast-feeding or pregnant.
- •- Participant withdrew consent from Study GBT440-031.
- •- Participant was lost to follow-up from Study GBT440-031.
- •- Participant requiring chronic dialysis.
- •- 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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