EUCTR2012-003989-40-NL
进行中（未招募）
不适用
A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
- 发起方
- Vertex Pharmaceuticals Incorporated
- 入组人数
- 501
- 状态
- 进行中（未招募）
- 最后更新
- 11年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Males and females, aged 12 years or older on the date of informed consent or, where appropriate, date of assent
- •Confirmed diagnosis of CF
- •Homozygous for the F508del CFTR mutation
- •FEV1 \=40% and \=90% of predicted normal for age, sex, and height
- •Willing to remain on a stable CF medication regimen through Week 24 or, if applicable, the Safety Follow up Visit
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 264
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 349
- •F.1\.3 Elderly (\>\=65 years) no
排除标准
- •An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before first dose of study drug
- •History of solid organ or hematological transplantation
- •History of alcohol or drug abuse in the past year
- •Ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening
- •Use of strong inhibitors, moderate inducers or strong inducers of CYP3A, including consumption of certain herbal medications (e.g., St. John's Wort) and certain fruit and fruit juices within 14 days before Day 1 of dosing
结局指标
主要结局
未指定
相似试验
进行中（未招募）
1 期
A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsCystic fibrosis in patients homozygous for the F508del-CFTR MutationMedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2012-003990-24-GBVertex Pharmaceuticals Incorporated559
进行中（未招募）
1 期
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisEUCTR2018-003986-33-BEArena Pharmaceuticals, Inc.330
进行中（未招募）
1 期
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisEUCTR2018-003986-33-GBArena Pharmaceuticals, Inc.330
进行中（未招募）
不适用
A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsCystic fibrosis in patients homozygous for the F508del-CFTR MutationMedDRA version: 17.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2012-003989-40-IEVertex Pharmaceuticals Incorporated501
进行中（未招募）
不适用
A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia - LVHJMen with benign prostatic hyperplasiaMedDRA version: 9.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasiaEUCTR2008-002841-21-ITEli Lilly and Company521