Trials / Completed
CompletedNCT03601637
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Months – 23 Months
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F/F).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LUM | Fixed Dose Combination (FDC) granules (LUM/IVA). |
| DRUG | IVA | FDC granules (LUM/IVA). |
Timeline
- Start date
- 2018-09-07
- Primary completion
- 2021-10-29
- Completion
- 2021-10-29
- First posted
- 2018-07-26
- Last updated
- 2023-01-06
- Results posted
- 2023-01-06
Locations
27 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03601637. Inclusion in this directory is not an endorsement.