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

NCT00632463 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2013-04-24

Study results available
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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

Interventions

BIOLOGICAL

RI-001

Dose 1

BIOLOGICAL

RI-001

Dose 2

BIOLOGICAL

RI-001

Placebo

Sponsors & Collaborators

  • ADMA Biologics, Inc.

    lead INDUSTRY

Principal Investigators

  • Upton Allen, MBBS · Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00632463 on ClinicalTrials.gov