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)

Unhealthy Children With a History of Prematurity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240929
• Other study ID #: MI-CP097
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2005
• Last updated: November 12, 2010
• Start date: September 2002
• Est. completion date: April 2003

Study information

• Verified date: November 2010
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Months to 6 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Unhealthy Children With a History of Prematurity

Intervention

Drug:
• MEDI-493
Active Comparator

Locations

Country	Name	City	State
United States	Packard Children's Hospital at Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.		Day 30
Secondary	Adverse events and serious adverse events for 30 days after each injection of study drug.		Day 30