CTRI/2011/04/001664已完成3 期
A Phase III Open-label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303 - CTBM100C2303E1
ovartis Healthcare Private Limited0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Completed all visits in study CTBM100C2303, and visit 4 took place not more than 5 days before enrollment into this study.
- •2. Confirmed diagnosis of cystic fibrosis patients with P. aeruginosa infection.
- •3. FEV1 at screening (study CTBM100C2303) must be between 25 percent and 80 percent of normal predicted values.
排除标准
- •1. Any use of inhaled anti-pseudomonal antibiotics between the termination of the core trial CTMB100C2303 and the enrollment into this study.
- •2. Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
研究者
相似试验
已完成
3 期
This is an open-label, single arm (uncontrolled) study in patients suffering from cystic fibrosis;who have completed their study participation in extension study one CTBM100C2303E1.CTRI/2011/09/002020ovartis Healthcare Pvt Ltd140
已完成
3 期
A Phase III Open Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS studymuscular dystrophyNeuromuscular disease10028302NL-OMON48973Santhera Pharmaceuticals (Switzerland),11
进行中（未招募）
1 期
An Open-label Extension Study to Evaluate the Long-term Safety andTolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over with Congenital Adrenal HyperplasiaCongenital Adrenal Hyperplasia due to 21-hydroxylase deficiencyEUCTR2021-004467-26-FRDiurnal Limited181
进行中（未招募）
1 期
A study to see if aceneuramic acid is safe and effective in treating people with Hereditary Inclusion Body Myopathy (HIBM), a rare muscle disease.EUCTR2016-000360-42-BGltragenyx Pharmaceutical Inc.165
进行中（未招募）
1 期
A study to see if aceneuramic acid is safe and effective in treating people with Hereditary Inclusion Body Myopathy (HIBM), a rare muscle disease.GNE Myopathy, also known as Hereditary Inclusion Body Myopatha\y (HIBM), Distal Myopathy with Rimmed Vacuoles (DMRV), Nonaka's disease, or quadriceps sparing myopathy (QSM)MedDRA version: 20.0Level: PTClassification code 10077945Term: GNE myopathySystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: LLTClassification code 10075048Term: Hereditary inclusion body myopathySystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2016-000360-42-ITTRAGENYX PHARMACEUTICAL INC.143