NCT05153317已完成3 期
A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 22
- 主要终点
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the long term safety, tolerability, efficacy and pharmacodynamics of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in CF participants 2 years of age and older.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed study drug treatment in the parent study (VX20-445-111 Part B, NCT04537793), or had study drug interruption(s) in the parent study, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of the parent study
排除标准
- •History of study drug intolerance in the parent study
- •History of poor compliance with ELX/TEZ/IVA and/or procedures in the parent study
- •Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
ELX/TEZ/IVA
Experimental
Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.
干预措施: ELX/TEZ/IVA (Drug)
ELX/TEZ/IVA
Experimental
Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.
干预措施: IVA (Drug)
结局指标
主要结局
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From Day 1 up to Week 196
次要结局
- Absolute Change in Sweat Chloride (SwCl)(From Baseline up to Week 192)
- Absolute Change in Lung Clearance Index (LCI) 2.5(From Baseline up to Week 192)
研究者
研究点 (22)
Loading locations...
相似试验
进行中（未招募）
3 期
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and OlderCystic FibrosisNCT06460506Vertex Pharmaceuticals Incorporated50
已完成
3 期
Long-term Open-Label Safety Study to Evaluate EN3409Low Back PainNeuropathic PainOsteoarthritisNCT01755546BioDelivery Sciences International304
已完成
3 期
Long-Term Safety Study of Retigabine Immediate Release (IR) as Adjunctive Therapy in the Treatment of Adults With Partial-Onset Seizures (POS)EpilepsyNCT01336621GlaxoSmithKline98
招募中
3 期
Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAEHereditary Angioedema (HAE)NCT06679881Pharvaris Netherlands B.V.170
已完成
3 期
An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)SchizophreniaNCT04820309Karuna Therapeutics566