Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del - Trial 2016-001004-33

Name: Clinical Trial 2016-001004-33
Creator: Vertex Pharmaceuticals Incorporated
Keywords: Cystic Fibrosis, clinical trial

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.

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2016-001004-33

Trial Details

EU Clinical Trials Register • 2016-001004-33

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

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 abnormalities

Congenital malformations, deformations and chromosomal abnormalities

Other specified congenital malformations

Special screening examination for congenital malformations, deformations and chromosomal abnormalities

Personal history of congenital malformations, deformations and chromosomal abnormalities

Data Source

Registry

EU Clinical Trials Register

Trial ID

2016-001004-33

Type

Non-Device Trial