NCT00632463

RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: ADMA Biologics, Inc. · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

RSV infections can develop into serious, life threatening conditions among immunocompromised patients. The objective of this study (ADMA 001) is to evaluate the safety and efficacy of RI-001 for the prevention of lower respiratory tract infections in immunocompromised patients identified as being infected with RSV in the upper respiratory tract.

Conditions

• Upper Respiratory Tract Infection
• Lower Respiratory Tract Infection

Interventions

Type	Name	Description
BIOLOGICAL	RI-001	Dose 1
BIOLOGICAL	RI-001	Dose 2
BIOLOGICAL	RI-001	Placebo

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-03-10
• Last updated: 2013-04-24
• Results posted: 2013-04-24

Locations

19 sites across 2 countries: United States, Canada