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NCT01775137 · ClinicalTrials.gov registry record · Phase 4
Ext. Long-term Safety Study in CF Patients: Single Arm TIP
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 45
- Enrollment target
NCT01775137: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT01775137 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 45 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01775137, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.
Primary Outcome
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or
Interventions
- DRUG TBM100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-11 |
| Phase | Phase 4 |
What the finished NCT01775137 record still lists
NCT01775137 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which TBM100 is the first listed.
NCT01775137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01775137 about?
NCT01775137 is a clinical study titled "Ext. Long-term Safety Study in CF Patients: Single Arm TIP". The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.
What is the current status of trial NCT01775137?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 45 participants. The study started on 2013-02. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01775137?
The interventions under investigation include: TBM100 (DRUG).
Who is sponsoring clinical trial NCT01775137?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01775137's enrollment target sits among peer trials
45 1354th of 2000 higher than 638 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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