Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract
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|ClinicalTrials.gov Identifier: NCT02254421|
Recruitment Status : Completed
First Posted : October 1, 2014
Results First Posted : May 11, 2018
Last Update Posted : September 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Syncytial Virus Infection||Drug: Presatovir Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract|
|Actual Study Start Date :||January 31, 2015|
|Actual Primary Completion Date :||April 17, 2017|
|Actual Study Completion Date :||April 17, 2017|
Participants will receive presatovir on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56.
Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube
Other Name: GS-5806
Placebo Comparator: Placebo
Participants will receive placebo to match presatovir on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56.
Placebo to match presatovir administered orally or via nasogastric tube
- Time-weighted Average Change in Nasal Respiratory Syncytial Viral (RSV) Load From Baseline to Day 9 [ Time Frame: Baseline to Day 9 ]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.
- Number of Supplemental O2-Free Days Through Day 28 [ Time Frame: Up to Day 28 ]
- Percentage of Participants Developing Respiratory Failure Requiring Mechanical Ventilation Through Day 28 [ Time Frame: Up to Day 28 ]
- Percentage of All-Cause Mortality Among Participants Through Day 28 [ Time Frame: Up to Day 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254421
|Study Director:||Gilead Study Director||Gilead Sciences|