AeroVanc (SAV005-04) – NOW ENROLLING
A Phase
III, randomized, double-blind, placebo-controlled study of AeroVanc for the
treatment of persistent methicillin-resistant Staphylococcus aureus lung
infection in cystic fibrosis patients (SAV005-04)
Protocol, purpose and
description: This study is a multi-center, randomized phase III
study to evaluate the clinical effectiveness of AeroVanc in persistent MRSA in
patients with Cystic Fibrosis.
CHKD
physicians involved: Laura Sass,
MD; Cynthia Epstein, MD; Frank Chocano,
MD
Learn
more about this clinical trial.
Or
contact Jennifer Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org or
Erin
McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org
Tobramycin inhalation powder or
other FDA approved inhaled antipseudomonal antibacterial drugs (CTBM100C2407) – NOW ENROLLING
A
prospective observational study in cystic fibrosis patients with chronic
respiratory Pseudomonas aeruginosa infection treated with TOBI® Podhaler™
(tobramycin inhalation powder) or other FDA approved inhaled antipseudomonal
antibacterial drugs (CTBM100C2407)
Protocol, purpose and
description: This
is a multicenter, prospective, two cohort, observational study over a 5-year
period in Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa
infection. The study will collect data over 1 year on respiratory function,
antibacterial effectiveness, and clinical outcomes of treatment with inhaled
antipseudomonal antibiotics and data over 5 years on microbiological and safety
assessments.
CHKD
physicians involved: Laura Sass, MD;
Cynthia Epstein, MD; Frank Chocano, MD
Learn
more about this clinical trial.
Or
contact Jennifer Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org or
Erin
McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org
A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic
Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation
(F/MF) – NOW ENROLLING
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating
the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic
Fibrosis Who Are Heterozygous for F508del Mutation and a Minimal Function Mutation
(F/MF) – VX17-445-102
Protocol, purpose and
description: This
study will evaluate the efficacy of VX-445 in triple combination (TC) with
tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who
are heterozygous for F508del and a minimal function mutation (F/MF subjects).
CHKD
physicians involved: Laura Sass, MD;
Cynthia Epstein, MD; Frank Chocano, MD
Learn
more about this clinical trial.
Or contact Erin McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org or
Jennifer
Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org
A Study
Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy –
ENROLLING SOON
A Phase 3, Open-label Study Evaluating the Long-term
Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic
Fibrosis Who Are Homozygous or Heterozygous for F508del Mutation – VX17-445-105
Protocol, purpose and
description: This
study will evaluate the long-term safety and tolerability of VX-445 in triple
combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with
cystic fibrosis (CF) who are homozygous or heterozygous for the F508del
mutation
CHKD
physicians involved: Laura Sass, MD;
Cynthia Epstein, MD; Frank Chocano, MD
Learn
more about this clinical trial.
Or
contact Erin McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org or
Jennifer
Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org
Tezacaftor/Ivacaftor
(VX16-661-114) – NOW ENROLLING
Phase 3b, Randomized, Double-blind,
Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and
Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced
Population Who Are Homozygous for the F508del-CFTR
Mutation (VX16-661-114)
Protocol, purpose and
description:
Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind,
placebo-controlled, parallel group, multicenter study in subjects aged 12 years
and older with CF who are homozygous for the F508del mutation on the CFTR gene
and who discontinued treatment with Orkambi due to respiratory symptoms
considered related to treatment. This study is designed to evaluate the safety
and efficacy of TEZ/IVA.
CHKD
physicians involved: Laura Sass, MD;
Cynthia Epstein, MD; Frank Chocano, MD
Learn more about this study.
Or
contact Erin McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org or
Jennifer
Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org
AeroVanc (SAV005-04) – NOW ENROLLING
A Phase
III, randomized, double-blind, placebo-controlled study of AeroVanc for the
treatment of persistent methicillin-resistant Staphylococcus aureus lung infection
in cystic fibrosis patients (SAV005-04)
Protocol, purpose and
description: This study is a multi-center, randomized phase III
study to evaluate the clinical effectiveness of AeroVanc in persistent MRSA in
patients with Cystic Fibrosis.
CHKD
physicians involved: Laura Sass,
MD; Cynthia Epstein, MD; Frank Chocano,
MD
Learn more about this study.
Or
contact Jennifer Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org or
Erin
McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org
Tobramycin inhalation powder or
other FDA approved inhaled antipseudomonal antibacterial drugs (CTBM100C2407) – NOW ENROLLING
A
prospective observational study in cystic fibrosis patients with chronic
respiratory Pseudomonas aeruginosa infection treated with TOBI® Podhaler™
(tobramycin inhalation powder) or other FDA approved inhaled antipseudomonal
antibacterial drugs (CTBM100C2407)
Protocol, purpose and
description: This
is a multicenter, prospective, two cohort, observational study over a 5-year
period in Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa
infection. The study will collect data over 1 year on respiratory function,
antibacterial effectiveness, and clinical outcomes of treatment with inhaled
antipseudomonal antibiotics and data over 5 years on microbiological and safety
assessments.
CHKD
physicians involved: Laura Sass, MD;
Cynthia Epstein, MD; Frank Chocano, MD
Learn more about this study.
Or
contact Jennifer Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org or
Erin
McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org
VX-661 in Combination With
Ivacaftor (VX15-661-113)
A Phase
3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability
of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age
With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation (VX15-661-113)
Protocol, purpose and
description: This
is a Phase 3, 2-part (Part A and Part B), open label, multicenter study
evaluating the PK, safety, and tolerability of multiple doses of VX-661 in
combination with ivacaftor in subjects 6 through 11 years of age with CF who
are homozygous or heterozygous for the F508del-CFTR mutation.
CHKD
physicians involved: Laura Sass, MD;
Cynthia Epstein, MD; Frank Chocano, MD
Learn more about this study.
Or
contact Erin McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org or
Jennifer
Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org