NCT02254421

Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower 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 Lower Respiratory Tract

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (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 lower respiratory tract infection (LRTI).

Conditions

• Respiratory Syncytial Virus Infection

Interventions

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

Timeline

• Start date: 2015-01-31
• Primary completion: 2017-04-17
• Completion: 2017-04-17
• First posted: 2014-10-01
• Last updated: 2018-09-24
• Results posted: 2018-05-11

Locations

17 sites across 5 countries: United States, France, South Korea, Sweden, Switzerland

Regulatory

• FDA-regulated drug study