NCT05348915终止3 期
An Open-label Extension Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease Who Have Participated in an Inclacumab Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 242
- 试验地点
- 50
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs).
研究概览
简要总结
This study is an open-label study to evaluate the safety of long-term administration of inclacumab in participants with sickle cell disease (SCD). Participants in this study will have completed a prior study of inclacumab.
详细描述
The study will include approximately 520 adult and adolescent participants (≥ 12 years of age) with SCD.
All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who meet all the following criteria will be eligible for study enrollment:
- •Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study.
- •Participant has completed the originating inclacumab study within 30 calendar days of the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related 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 inclacumab.
- •Female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day
- •Note: Female participants who become of childbearing potential during the study must be willing to have a negative urine pregnancy test to remain in the study.
- •If sexually active, female participants of childbearing potential must consistently use highly effective methods of contraception consistently throughout the study and for at least 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug.
- •Participant has provided written informed consent/assent. For underage participants, both the consent of the participant's legal representative or legal guardian and the participant's assent (where applicable) must be obtained based on local requirement.
排除标准
- •Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:
- •Female participant who is breastfeeding or pregnant.
- •Participant had an infusions-related reaction (IRR) in the originating inclacumab clinical study.
- •Participant withdrew consent from the originating inclacumab clinical study.
- •Participant was lost to follow-up from the originating inclacumab clinical study.
- •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.
研究组 & 干预措施
Inclacumab 30 mg/kg
Experimental
Inclacumab 30 mg/kg administered intravenously (IV)
干预措施: Inclacumab (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs).
时间窗: Day 1 through study completion, an estimate of 5 years
次要结局
- Annualized rate of VOCs(Day 1 through study completion, an estimate of 5 years)
- Annualized rate of VOCs that require admission to a healthcare facility and treatment.(Day 1 through study completion, an estimate of 5 years)
- Annualized rate of all SCD-related urgent care visits to the clinic, emergency room, and hospital.(Day 1 through study completion, an estimate of 5 years)
- Annualized number of days of inpatient hospitalization for a VOC.(Day 1 through study completion, an estimate of 5 years)
- Annualized rate of complicated VOCs.(Day 1 through study completion, an estimate of 5 years)
- Annualized rate of RBC transfusions.(Day 1 through study completion, an estimate of 5 years)
- Proportion of total days missed from school or work due to SCD pain symptoms for the first 48 weeks.(Day 1 through study completion, an estimate of 5 years)
研究者
研究点 (50)
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