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)
Information source: MedImmune LLC
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: -Unhealthy Children With a History of Prematurity
Intervention: MEDI-493 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: MedImmune LLC Official(s) and/or principal investigator(s):
Genevieve Losonsky, M.D., Study Director, Affiliation: "Unaffliliated"
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Crossover Assignment, Safety Study
Primary outcome: 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: Adverse events and serious adverse events for 30 days after each injection of study drug.
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.
Eligibility
Minimum age: 5 Months.
Maximum age: 6 Months.
Gender(s): Both.
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.
Locations and Contacts
Packard Children's Hospital at Stanford, Palo Alto, California 94304, United States
Additional Information
Starting date: September 2002
Ending date: April 2003
Last updated: November 9, 2007
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