A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00421304
First received: January 9, 2007
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.


Condition Intervention Phase
Respiratory Syncytial Virus (RSV)
Biological: Motavizumab
Other: Biological/Vaccine: Motavizumab
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Treatment of Children Hospitalized With RSV Illness

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Description of Motavizumab levels and viral load in the upper respiratory tract after a single 30 mg/kg or 100 mg/kg IV dose of Motavizumab in children who are hospitalized with RSV infection. (Viral cultures and RT-PCR) [ Time Frame: September 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length (from randomization) of hospitalization after Motavizumab or placebo is used to treat RSV illness in hospitalized children [ Time Frame: September 2009 ] [ Designated as safety issue: Yes ]
  • Evaluate effect of Motavizumab on severity of RSV illness during hospitalization [ Time Frame: September 2009 ] [ Designated as safety issue: Yes ]
  • The frequency of medically-attended wheezing in the 12 months following randomization as measured by documented events of wheezing that are evaluated by a healthcare provider [ Time Frame: September 2009 ] [ Designated as safety issue: Yes ]
  • Summary of Motavizumab serum levels and the number and percentage of patients with detectable anti-Motavizumab antibodies (PK and immunogenicity assays) [ Time Frame: September 2009 ] [ Designated as safety issue: No ]
  • Describe the effect of Motavizumab on markers of inflammation as measured by gene microarray and cytokine levels [ Time Frame: September 2009 ] [ Designated as safety issue: No ]
  • Safety and tolerability of Motavizumab as measured by adverse or serious adverse events through Study Day 90 and Serum chemistry, complete blood count (CBC), and platelets at baseline and at Study Days 7 and 30. [ Time Frame: September 2009 ] [ Designated as safety issue: Yes ]

Enrollment: 118
Study Start Date: January 2007
Study Completion Date: January 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MEDI-524 or Motavizumab
Biological: Motavizumab
Will receive a single dose of IV of Motavizumab (100mg/kg)
Experimental: 2
MEDI-524 or Motavizumab
Other: Biological/Vaccine: Motavizumab
A single IV dose of placebo (30 mg/kg).
Placebo Comparator: 3
Placebo
Other: Placebo
A single IV dose of placebo (30 or 100 mg/kg).

Detailed Description:

The primary objective of this study is to describe the effect of a single 30 mg/kg or 100 mg/kg intravenous (IV) dose of Motavizumab compared to placebo on study drug levels and viral load as measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children ≤12 months of age who are hospitalized with lower respiratory tract illness.

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Children must meet all of the following criteria:

  • Previously healthy
  • Age less or equal to 12 months at the time of randomization
  • Gestational age more or equal to 36 weeks
  • Hospitalized for lower respiratory tract illness (i.e., RSV bronchiolitis and/or pneumonia)
  • Documented positive RSV test within 48 hours prior to randomization
  • Randomization within 12 hours of the decision to hospitalize a child for RSV illness
  • Written informed consent obtained from the patient's parent(s)/legal guardian

Exclusion Criteria:

Children must have none of the following:

  • Prior receipt of or receiving ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
  • Any use of systemic or inhaled steroids within the past 30 days prior to randomization
  • Intubation for ventilatory support at randomization
  • Any medically significant underlying ongoing chronic illness or organ system dysfunction, or other known acute illness except for RSV infection
  • Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
  • Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed)
  • Mechanical ventilation at any time prior to the onset of the current RSV infection
  • Congenital heart disease [children with medically or surgically closed patent ductus arteriosis (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed]
  • Previous reaction to IVIG, blood products, or other foreign proteins
  • Prior use of IVIG, palivizumab (SynagisÒ), or other immunoglobulin products within the past 2 months
  • Currently receiving other investigational agents or have received any other investigational agents within the 3 months prior to randomization
  • Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421304

  Show 34 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: M. Pamela Griffin, M.D. MedImmune LLC
  More Information

Additional Information:
No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M. Pamela Griffin, MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00421304     History of Changes
Other Study ID Numbers: MI-CP141
Study First Received: January 9, 2007
Last Updated: June 27, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 16, 2014