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)
Completed · Phase 2
Conditions studied: -Unhealthy Children With a History of Prematurity
In brief
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.
Key facts
- Study ID
- NCT00240929
- Run by
- MedImmune LLC
- People needed
- 150
- Starts
- 2002-09-01
- Expected to finish
- 2003-04-01
- Last updated by the study team
- 2010-11-15
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Packard Children's Hospital at Stanford — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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