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ongoing trials trial from other registries

Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy Volunteers & People With Cystic Fibrosis - Phase 1|Phase 2 - Recruiting

  • Year: 2023
  • Date:
  • Author: Cystetic Medicines, Inc.|DevPro Biopharma
Source

https://ClinicalTrials.gov/show/NCT05802264

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

Controlled: No.1 Randomised: No.2 Open: Yes.3 Single blind: No.4 Double blind: No.5 Parallel group: No.6 Cross over: No

Participants

Principal inclusion criteria: 1.Subjects From Study VX16-809-122 Part B (Study 122) - Completed the 24-week Treatment Period and the Safety Followup Visit in Study 122B 2.Subjects Not From Study 122 - Subjects will be 1 to less than 2 years of age - Homozygous for the F508del mutation (F/F)

Interventions

Long-term lumacaftor/ivacaftor (LUM/IVA) treatment

Outcome measures

Primary end point(s): Safety and tolerability as assessed by the number of adverse events (AEs) and serious adverse events (SAEs)

Related topics

CFTR modulators therapy

Keywords: Child; Aminophenols; CFTR Modulators; Genetic Predisposition to Disease; Orkambi; pharmacological_intervention; VX-770; ivacaftor; lumacaftor; VX-809;