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NCT02254421 · ClinicalTrials.gov registry record · Phase 2
Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract
A Phase 2 study of Respiratory Syncytial Virus Infection, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 17
- Study locations
NCT02254421: Completed Phase 2 study of Respiratory Syncytial Virus Infection, sponsored by Gilead Sciences.
NCT02254421 is a Phase 2 study of Respiratory Syncytial Virus Infection that has completed, run by Gilead Sciences. The registered enrollment target is 60 participants, below the 993-participant average among 4 other Respiratory Syncytial Virus Infection trials with a reported enrollment target (94% lower). The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02254421, a Phase 2 study of Respiratory Syncytial Virus Infection, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 17
- Study locations
Study Summary
The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).
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 factors.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Presatovir
Study Locations (17)
Other
- Hopital Saint-Louis, APHP - Paris
- Hopital Foch - Suresnes
- CHU de Bordeaux - Talence
- Seoul Saint Mary's Hospital - Seoul
- Karolinska Institutet - Stockholm
- University Clinical Basel - Basel
California
- City of Hope - Duarte
Illinois
- University of Chicago - Chicago
Maryland
- John Hopkins - Baltimore
Massachusetts
- Dana Farber Cancer Institute - Boston
Michigan
- University of Michigan - Ann Arbor
Minnesota
- University of Minnesota - Minneapolis
New York
- New York Weill Cornell Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2015-01-31 |
| Est. Completion | 2017-04-17 |
| Phase | Phase 2 |
What the finished NCT02254421 record still lists
NCT02254421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 993-participant average among 4 other Respiratory Syncytial Virus Infection trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Respiratory Syncytial Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02254421 lists 17 locations in 12 states (Other, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT02254421 about?
NCT02254421 is a clinical study titled "Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract". The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).
What is the current status of trial NCT02254421?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2015-01-31. Estimated completion is 2017-04-17.
What conditions does trial NCT02254421 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infection.
What interventions are being tested in trial NCT02254421?
The interventions under investigation include: Placebo (DRUG), Presatovir (DRUG).
Who is sponsoring clinical trial NCT02254421?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02254421 being conducted?
This trial has 17 study locations across California, Illinois, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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