Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT03601637 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 61 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT03601637 record still lists
NCT03601637 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which IVA is the first listed.
NCT03601637 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03601637's enrollment target sits among peer trials
61 1803rd of 2000 higher than 197 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04115306 · 61 participants · Phase 1
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
- NCT05070845 · 61 participants · Phase 2
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
- NCT05187832 · 61 participants · Phase 1
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
- NCT05269316 · 61 participants · Phase 1
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI