Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis - Full Text View

Purpose

The purpose of this study is to evaluate the safety, efficacy, and PK comparing Pagibaximab Injection to placebo. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23.

Condition	Intervention	Phase
Staphylococcal Sepsis	Drug: Pagibaximab (formerly BSYX-A110)	Phase II Phase III

MedlinePlus related topics:

Sepsis

ChemIDplus related topics:

Pagibaximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight (VLBW) Neonates for the Prevention of Staphylococcal Sepsis

Further study details as provided by Biosynexus Incorporated:

Primary Outcome Measures:

Safety and pharmacokinetics [ Time Frame: 0 - 35 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacodynamics and pharmacokinetics of pagibaximab, following IV administration of a six-dose (100mg/kg) regimen of pagibaximab. [ Time Frame: 0 - 35 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1550
Study Start Date:	February 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Placebo	Drug: Pagibaximab (formerly BSYX-A110) Dosed on Days 0, 1, 2, 9, 16 and 23.
100 mg/kg: Experimental Pagibaximab at 100 mg/kg intravenously at Days 0, 1, 2, 9, 16 and 23.	Drug: Pagibaximab (formerly BSYX-A110) Pagibaximab at 100 mg/kg intravenously on Days 0, 1, 2, 9, 16 and 23

Detailed Description:

This is a Phase 2b/3, randomized, double-blind, multicenter, placebo-controlled study evaluating the safety, efficacy and pharmacokinetics (PK) of pagibaximab (100 mg/kg/dose) in comparison to placebo for the prevention of staphylococcal sepsis in VLBW infants (600 -1200 grams). Subjects monitored for treatment related adverse events and tolerability to infusion of study drug. Neonatal sepsis will be assessed in the presence of clinical signs and symptoms and one blood culture positive for S. aureus or two blood cultures positive for Coagulase Negative Staphylococci (CoNS). The study period will be 35 days after the first dose or until, death, discharge, or transfer, whichever occurs first.

Eligibility

Ages Eligible for Study:	up to 48 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

In-patient at a Neonatal Intensive Care Unit (NICU)
Informed consent obtained from the legally authorized representative
Less than 48 hours old at the time of first infusion
Birth weight between 600 grams and 1200 grams
Estimated gestation age ≤33 weeks

For multiple gestations, twins may be enrolled if they each meet the entry criteria. They will both be assigned to the same treatment group.

Exclusion Criteria:

Infants with history of a hypersensitivity or severe vasomotor reaction to any antibody preparation.
Infants with proven staphylococcal infection prior to randomization.
Infants with a concomitant infection or other medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.
Immunodeficiency other than due to prematurity.
Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study.
Severe congenital or chromosomal anomaly that would limit life expectancy or required corrective measures during the period of this study
Uncontrolled seizures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646399

Contacts


Contact: John Kokai-Kun, PhD	301-330-5800 ext 1172	johnkun@biosynexus.com

Contact: Jimmy Mond, MD	301-330-5800 ext 1161	jimmymond@biosynexus.com

Locations


United States, Maryland
	Biosynexus Incorporated	Not yet recruiting
	Gaithersburg, Maryland, United States, 20877
	Contact: John Kokai-Kun, PhD 301-330-5800 ext 1172 johnkun@biosynexus.com

Sponsors and Collaborators

Biosynexus Incorporated

More Information

Biosynexus Incorporated This link exits the ClinicalTrials.gov site

Responsible Party:	Biosynexus Incorporated ( Irwin Scher, President and CEO )
Study ID Numbers:	MAB-N007
First Received:	March 26, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00646399
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biosynexus Incorporated:

Staphylococcal

Coagulase Negative Staphylococcus

Monoclonal antibodies

Very Low Birth Weight Infants

Prophylaxis

Study placed in the following topic categories:

Birth Weight

Systemic Inflammatory Response Syndrome

Bacterial Infections

Bacteremia

Inflammation

Body Weight

Antibodies, Monoclonal

Coagulase

Staphylococcal Infections

Signs and Symptoms

Sepsis

Gram-Positive Bacterial Infections

Antibodies

Additional relevant MeSH terms:

Pathologic Processes

Infection

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Biosynexus Incorporated
Information provided by:	Biosynexus Incorporated
ClinicalTrials.gov Identifier:	NCT00646399