# A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

> **NCT03125395** · PHASE3 · COMPLETED · sponsor: **Vertex Pharmaceuticals Incorporated** · enrollment: 57 (actual)

## Conditions studied

- Cystic Fibrosis

## Interventions

- **DRUG:** LUM/IVA

## Key facts

- **NCT ID:** NCT03125395
- **Lead sponsor:** Vertex Pharmaceuticals Incorporated
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-05-12
- **Primary completion:** 2019-07-17
- **Final completion:** 2019-07-17
- **Target enrollment:** 57 (ACTUAL)
- **Last updated:** 2020-08-07


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03125395

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03125395, "A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT03125395. Licensed CC0.

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