Protocol Information

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Title GROW-IP-16: A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Study Evaluating the Role of Oral Glutathione on Growth Parameters in Children with Cystic Fibrosis
Description Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del

Study visits will be in downtown Buffalo
Objective This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of Lumacaftor/Ivacaftor (LUM/IVA) in subjects 2 through 5 years of age (inclusive) with Cystic Fibrosis (CF), homozygous for F508del. Subjects who participate in Part A may participate in Part B, if patient meet the eligibility criteria.

Principal Investigator GOETZ, DANIELLE
Age Group Children
Drugs Involved
Clinical Trials.gov http://www.clinicaltrials.gov/ct2/show/NCT03020719/
Status Open
Key Eligibility Children Aged 2- 5 Years
Cystic Fibrosis
Homozygous for the F508del-CFTR Mutation
Disease Group Children's Health/Pediatrics; Cystic Fibrosis; Lung/Pulmonary Diseases
Treatment Lumacaftor/Ivacaftor
Contact NADINE CACI
716-878-7524
nadineca@buffalo.edu