CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 189 enrolled
Drug / intervention
Presatovir +1 moredrug
Likely dose
Presatovir 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02254408
NCT02254408Phase 2Completed
CompareCT.gov

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 Upper Respiratory Tract

Gilead Sciences·interventional·Posted Oct 1, 2014·Updated Aug 6, 2018

In Brief

A Phase 2 clinical trial evaluating Presatovir and Placebo for Respiratory Syncytial Virus. Completed, enrolled 189 participants across 68 sites in 15 countries.

Detailed 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 upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory tract complication, being free of any supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus
CountriesAustralia, Brazil, Canada, France, Germany, Israel, Netherlands, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 1, 2014
Enrollment StartJan 23, 2015
Primary CompletionJul 14, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.8 years ago

Interventions

Presatovirdrug

Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube

Placebodrug

Tablets administered orally or via nasogastric tube