NCT02254408

Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
DRUG	Presatovir	Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube
DRUG	Placebo	Tablets administered orally or via nasogastric tube

Timeline

• Start date: 2015-01-23
• Primary completion: 2017-07-14
• Completion: 2017-07-14
• First posted: 2014-10-01
• Last updated: 2018-08-06
• Results posted: 2018-08-06

Locations

68 sites across 15 countries: United States, Australia, Brazil, Canada, France, Germany, Israel, Netherlands, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study