CFDB - Cystic Fibrosis DataBase

  1. Home
  2. Database
Search (?)
at least one term
all terms
Advanced search
ongoing trials trial from www.clinicaltrials.gov

A Phase 3 Open-label Study Evaluating the Longterm Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes

  • Year: 2021
  • Date: April 22, 2021
  • Author:
Source

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005914-33/DE/

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

Interventional - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment

Participants

Cystic Fibrosis|Aspergillosis - 8 Years to 17 Years   (Child)

Interventions

Drug: Posaconazole 100 MG [Noxafil]|Drug: Posaconazole 40 MG/ML

Outcome measures

Pharmacokinetic parameters of posaconazole|Aspergillus isolation from sputum cultures|Patients with a favourable clinical response and no signs of Aspergillus infection|Patients with no signs of Aspergillus infection|The proportion of participants experiencing AEs and SAEs

Keywords: Adolescent; Adult; Antifungal Agents; Child; pharmacological_intervention; Allergic Bronchopulmonary Aspergillosis -ABPA-; Aspergillus; Fungi; Infection; Respiratory Tract Infections; Respiratory Tract Diseases; posaconazole;