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A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis)

Primary Purpose

-Unhealthy Children With a History of Prematurity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MEDI-493
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for -Unhealthy Children With a History of Prematurity

Eligibility Criteria

5 Months - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The child must have been born at greater than or equal to 35 weeks gestation and be greater than or equal to 6 months of age at the time of randomization (child must be randomized on or before their 6-month birthday) The child's parent or legal guardian must provide written informed consent; and The child must be able to complete the follow-up visits on Study Days 30 and 60 within the protocol specified windows (±2 days) Parent/legal guardian of patient has available telephone access. Exclusion Criteria: Be hospitalized; Birth hospitalization > 6 weeks duration; Be receiving mechanical ventilation at the time of study entry (including CPAP); Bronchopulmonary dysplasia (BPD), defined as history of prematurity and associated chronic lung disease with oxygen requirement for >28 days; Congenital heart disease (CHD). (Children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled.) Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency; Any of the following laboratory findings in blood obtained within 7 days prior to study entry: BUN or creatinine >1.5´ the upper limit of normal for age AST (SGOT) or ALT (SGPT) >1.5´ the upper limit of normal for age hemoglobin <9.0 gm/dL white blood cell count <4,000 cells/mm3 platelet count <110,000 cells/mm3 Acute illness or progressive clinical disorder; History of recent difficult venous access; Active infection, including acute RSV infection; Previous reaction to IGIV, blood products, or other foreign proteins; Received within the past 120 days or currently receiving IGIV, other immunoglobulin products, or any investigational agents; Have ever received palivizumab; Currently participating in any investigational study; or Previously participated in any investigational study of RSV vaccines or monoclonal antibodies.

Sites / Locations

  • Packard Children's Hospital at Stanford

Outcomes

Primary Outcome Measures

adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.

Secondary Outcome Measures

Adverse events and serious adverse events for 30 days after each injection of study drug.

Full Information

First Posted
October 14, 2005
Last Updated
November 12, 2010
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00240929
Brief Title
A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis)
Official Title
A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis), A Humanized Respiratory Syncytial Virus Monoclonal Antibody, in Children With a History of Prematurity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

5. Study Description

Brief Summary
A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence A or B.
Detailed Description
Phase II, Double-blind, two-period, cross-over study to be conducted at 20 sites the U.S. A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence: Sequence A (single dose of the liquid formulation on Study Day 0 and a single dose of the lyophilized formulation on Study Day 30) or Sequence B (single dose of the lyophized forumation on Study Day 0 and single dose of the liquid formulation on Study Day 30). Children will be followed for adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
-Unhealthy Children With a History of Prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MEDI-493
Other Intervention Name(s)
Synagis
Intervention Description
Active Comparator
Primary Outcome Measure Information:
Title
adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Adverse events and serious adverse events for 30 days after each injection of study drug.
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The child must have been born at greater than or equal to 35 weeks gestation and be greater than or equal to 6 months of age at the time of randomization (child must be randomized on or before their 6-month birthday) The child's parent or legal guardian must provide written informed consent; and The child must be able to complete the follow-up visits on Study Days 30 and 60 within the protocol specified windows (±2 days) Parent/legal guardian of patient has available telephone access. Exclusion Criteria: Be hospitalized; Birth hospitalization > 6 weeks duration; Be receiving mechanical ventilation at the time of study entry (including CPAP); Bronchopulmonary dysplasia (BPD), defined as history of prematurity and associated chronic lung disease with oxygen requirement for >28 days; Congenital heart disease (CHD). (Children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled.) Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency; Any of the following laboratory findings in blood obtained within 7 days prior to study entry: BUN or creatinine >1.5´ the upper limit of normal for age AST (SGOT) or ALT (SGPT) >1.5´ the upper limit of normal for age hemoglobin <9.0 gm/dL white blood cell count <4,000 cells/mm3 platelet count <110,000 cells/mm3 Acute illness or progressive clinical disorder; History of recent difficult venous access; Active infection, including acute RSV infection; Previous reaction to IGIV, blood products, or other foreign proteins; Received within the past 120 days or currently receiving IGIV, other immunoglobulin products, or any investigational agents; Have ever received palivizumab; Currently participating in any investigational study; or Previously participated in any investigational study of RSV vaccines or monoclonal antibodies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Genevieve Losonsky, M.D.
Organizational Affiliation
"Unaffliliated"
Official's Role
Study Director
Facility Information:
Facility Name
Packard Children's Hospital at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis)

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