Status:
COMPLETED
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)
Lead Sponsor:
MedImmune LLC
Conditions:
-Unhealthy Children With a History of Prematurity
Eligibility:
All Genders
5-6 years
Phase:
PHASE2
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2003
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00240929
Start Date
September 1 2002
End Date
April 1 2003
Last Update
November 15 2010
Active Locations (1)
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1
Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304