CFDB - Cystic Fibrosis DataBase

ongoing trials trial from www.clinicaltrials.gov

A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation

Study design (if review, criteria of inclusion for studies)

Interventional - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment

Participants

Chronic Pseudomonas Aeruginosa Infection|Cystic Fibrosis - 18 Years and older   (Adult, Older Adult)

Interventions

Drug: BX004-A|Drug: Placebo

Outcome measures

Safety and tolerability

Keywords: Phage therapy; Anti-bacterial agents; pharmacological_intervention; Bacterial Infections; Infection; \Pseudomonas aeruginosa; Pseudomonas; Respiratory Tract Diseases; Respiratory Tract Infections;