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NCT03601637 · ClinicalTrials.gov registry record · Phase 3
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 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 61
- Enrollment target
NCT03601637 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 61 participants.
The verdict
NCT03601637, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 61 participants
- Enrollment target
Study 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).
Interventions
- DRUG IVA
- DRUG LUM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2018-09-07 |
| Est. Completion | 2021-10-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03601637
The ClinicalTrials.gov registry entry for NCT03601637 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IVA is the first listed.
NCT03601637 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03601637 about?
NCT03601637 is a clinical study titled "Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del". 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).
What is the current status of trial NCT03601637?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2018-09-07. Estimated completion is 2021-10-29.
What interventions are being tested in trial NCT03601637?
The interventions under investigation include: IVA (DRUG), LUM (DRUG).
Who is sponsoring clinical trial NCT03601637?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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