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NCT02135614 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 189
- Enrollment target
NCT02135614: Completed Phase 2 study, sponsored by Gilead Sciences.
NCT02135614 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 189 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02135614, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 189 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the effects of presatovir on respiratory syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute respiratory infectious symptoms. Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days postdose. Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change in viral load as the primary endpoint.
Primary Outcome
The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Interventions
- DRUG Presatovir
- DRUG Presatovir placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2014-06-09 |
| Est. Completion | 2017-04-12 |
| Phase | Phase 2 |
What the finished NCT02135614 record still lists
NCT02135614 is an interventional study that assigns participants to a tested intervention. The registered 189 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 2 interventions - of which Presatovir is the first listed.
NCT02135614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02135614 about?
NCT02135614 is a clinical study titled "Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection". The primary objective of this study is to evaluate the effects of presatovir on respiratory syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute respiratory infectious symptoms. Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days...
What is the current status of trial NCT02135614?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 189 participants. The study started on 2014-06-09. Estimated completion is 2017-04-12.
What interventions are being tested in trial NCT02135614?
The interventions under investigation include: Presatovir (DRUG), Presatovir placebo (DRUG).
Who is sponsoring clinical trial NCT02135614?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02135614's enrollment target sits among peer trials
189 355th of 2000 higher than 1,645 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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