# Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation

> **NCT04235140** · PHASE3 · COMPLETED · sponsor: **Vertex Pharmaceuticals Incorporated** · enrollment: 52 (actual)

## Conditions studied

- Cystic Fibrosis

## Interventions

- **DRUG:** LUM/IVA

## Key facts

- **NCT ID:** NCT04235140
- **Lead sponsor:** Vertex Pharmaceuticals Incorporated
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-02-24
- **Primary completion:** 2023-08-22
- **Final completion:** 2023-08-22
- **Target enrollment:** 52 (ACTUAL)
- **Last updated:** 2024-09-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04235140

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04235140, "Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT04235140. Licensed CC0.

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