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NCT03537651 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 130
- Enrollment target
NCT03537651 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 130 participants.
The verdict
NCT03537651, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 130 participants
- Enrollment target
Study Summary
This study evaluates the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.
Interventions
- DRUG IVA
- DRUG TEZ/IVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2018-04-25 |
| Est. Completion | 2023-09-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03537651
The ClinicalTrials.gov registry entry for NCT03537651 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 130 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.
NCT03537651 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03537651 about?
NCT03537651 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation". This study evaluates the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.
What is the current status of trial NCT03537651?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 130 participants. The study started on 2018-04-25. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT03537651?
The interventions under investigation include: IVA (DRUG), TEZ/IVA (DRUG).
Who is sponsoring clinical trial NCT03537651?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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