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

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

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

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:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:

Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013