NCT03061331

Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	LUM/IVA	LUM 400 mg/IVA 250 mg every 12 hours (q12h)
DRUG	Placebo	No Active Drug

Timeline

• Start date: 2017-01-31
• Primary completion: 2017-09-06
• Completion: 2017-10-04
• First posted: 2017-02-23
• Last updated: 2018-10-02
• Results posted: 2018-10-02

Locations

2 sites across 1 country: Netherlands

Regulatory

• FDA-regulated drug study