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) - Full Text View

Sponsor:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00240929

Purpose

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.

Condition	Intervention	Phase
-Unhealthy Children With a History of Prematurity	Drug: MEDI-493	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Crossover Assignment, Safety Study
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

Resource links provided by NLM:

Drug Information available for: Palivizumab

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

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. [ Time Frame: Day 30 ]

Secondary Outcome Measures:

Adverse events and serious adverse events for 30 days after each injection of study drug. [ Time Frame: Day 30 ]

Enrollment:	150
Study Start Date:	September 2002
Study Completion Date:	April 2003

Intervention Details:

Active Comparator

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

Ages Eligible for Study:	5 Months to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240929

Locations

United States, California
Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:

Genevieve Losonsky, M.D.

"Unaffliliated"

More Information

No publications provided

Study ID Numbers:	MI-CP097
Study First Received:	October 14, 2005
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00240929 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antiviral Agents
Palivizumab
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010