2016-001004-33

Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del

Vertex Pharmaceuticals Incorporated·EU Clinical Trials Register
Study focus
Disease/Condition
Cystic Fibrosis
Sponsor & location
Primary sponsor
Vertex Pharmaceuticals Incorporated
Timeline & enrollment
Phase
N/A
Start date
N/A
End date
N/A
Primary outcome

- Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject

ICD-10 classifications
Family history of congenital malformations, deformations and chromosomal abnormalitiesCongenital malformations, deformations and chromosomal abnormalitiesOther specified congenital malformationsSpecial screening examination for congenital malformations, deformations and chromosomal abnormalitiesPersonal history of congenital malformations, deformations and chromosomal abnormalities
Data source
Registry
EU Clinical Trials Register
Trial ID
2016-001004-33
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for 2016-001004-33 through Pure Global AI's free database. This phase not specified trial is sponsored by Vertex Pharmaceuticals Incorporated and is currently status unknown. The study focuses on Cystic Fibrosis.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to EU Clinical Trials Register data, helping medical device and pharmaceutical companies navigate clinical research efficiently.