NCT04058210Approved For Marketing不适用
VX-445/TEZ/IVA Triple Combination Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function CFTR Mutation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
研究概览
简要总结
The purpose of this program is to provide elexacaftor(ELX, VX-445)/tezacaftor(TEZ)/ivacaftor(IVA) combination therapy to CF patients in critical need who are 12 years of age and older, heterozygous for F508del and a minimal function (MF) mutation in response to unsolicited physician requests.
研究设计
- 研究类型
- Expanded Access
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
- •Patients who have F/MF genotypes AND who meet at least 1 of the following criteria:
- •The percent predicted forced expiratory volume in 1 second (ppFEV1) is <40 for a minimum of 2 months before the date of the request, OR
- •Documentation of being active on a lung transplant waiting list or documentation of being evaluated for lung transplantation, but deemed unsuitable because of contraindications
排除标准
- •Patients with severe hepatic impairment (Child-Pugh Class C)
- •History of any other comorbidity that, in the opinion of the treating physician, might pose undue risk in administering ELX/TEZ/IVA to the patient
- •Other protocol defined Inclusion/Exclusion criteria may apply
研究者
相似试验
Approved For Marketing
不适用
ELX/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients With at Least One F508del MutationCystic FibrosisNCT04702360Vertex Pharmaceuticals Incorporated
Available
不适用
Expanded Access to VenetoclaxChronic Lymphocytic Leukemia (CLL)Acute Myeloid Leukemia (AML)Non-Hodgkin's LymphomaAcute Lymphoblastic Leukemia (ALL)Plasma Cell LeukemiaMultiple MyelomaAmyloidosisNCT03123029AbbVie
No Longer Available
不适用
Expanded Access to VAL-083CancerNCT03138629Kintara Therapeutics, Inc.
No Longer Available
不适用
Expanded Access to NavitoclaxAcute Lymphocytic Leukemia (ALL)Lymphoblastic LymphomaMyelofibrosisNCT03592576AbbVie
No Longer Available
不适用
Expanded Access Program of Venetoclax and Navitoclax for Pediatric Patients with Relapsed or Refractory ALL or LLNCT05215405Kathleen Ludwig