Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110 - Full Text View

Sponsors and Collaborators:	Biosynexus Incorporated GlaxoSmithKline
Information provided by:	Biosynexus Incorporated
ClinicalTrials.gov Identifier:	NCT00631800

Purpose

The purpose of this study is to evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a 3-dose regimen on Study Days 0, 7, and 14.

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

MedlinePlus related topics: Sepsis Staphylococcal Infections

Drug Information available for: Immunoglobulins Globulin, Immune Pagibaximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Randomized, Double Blind, Placebo Controlled, Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110, for the Prevention of Staphylococcal Infection

Further study details as provided by Biosynexus Incorporated:

Primary Outcome Measures:

Safety and pharmacokinetics [ Time Frame: 0 - 56 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacodynamics, sepsis/bloodstream infection [ Time Frame: 0 - 56 days ] [ Designated as safety issue: Yes ]

Enrollment:	88
Study Start Date:	May 2003
Study Completion Date:	November 2004
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Placebo	Drug: Pagibaximab (formerly BSYX-A110) Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14
60 mg/kg: Experimental 60 mg/kg was given on Days 0, 7, 14	Drug: Pagibaximab (formerly BSYX-A110) Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14
90 mg/kg: Experimental 90 mg/kg was given on Days 0, 7, 14	Drug: Pagibaximab (formerly BSYX-A110) Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14

Detailed Description:

This Phase II study will be a randomized, double blind, placebo controlled study of BSYX-A110 in very low birth weight neonates. A total of 80 infants will be dosed in this study. Participants will receive either BSYX-A110 or placebo, at 60 mg/kg or 90 mg/kg. The Study Drug will be administered at 48-120 hours of life, 7 days after the initial dose, and 14 days after the initial dose for all dose groups.

Eligibility

Ages Eligible for Study:	up to 120 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients must meet all of the following criteria at the time of first infusion (Day 0):

48-120 hours of age, inclusive
Birth weight of 700-1300 grams
Inpatient in a Neonatal Intensive Care Unit
Written informed consent obtained from the parent(s) or legal guardian

Multiple gestations:

Siblings from multiple gestations may be enrolled if they each meet the entry criteria
No more than 4 subjects in any birth weight cohort may be siblings

Exclusion Criteria:

Patients may have none of the following at the first dose:

Survival not expected for at least 1 week after infusion
Clinically overt systemic infection, as determined by history, physical examination, and positive culture from a normally sterile site. (Infuse only when infant clinically stable and cultures negative for 48 hours. If being evaluated for sepsis, decision to infuse may be deferred as allowed by protocol infusion window. Infusions outside of protocol window must be approved by Sponsor.)
Severe congenital anomalies or genetic disorders that are likely to be fatal or that may interfere with drug distribution or metabolism, as determined by history and/or physical examination, and including but not limited to:

i. Trisomy 13 ii. Trisomy 18 iii. Hypoplastic Left Heart Syndrome iv. Omphalocele v. Gastroschesis vi. Holoprosencephaly
Known or suspected hepatic or renal insufficiency
Clinically uncontrolled seizures
Immunodeficiency other than due to prematurity
A history of standard immune globulin administration prior to first study drug infusion (excluding Hepatitis B Immune Globulin, HBIG)
Any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin G, or blood products
Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study; including enrollment in another investigational study for a product under an IRB-approved protocol
Expectation that the patient will not be able to be followed for the duration of the study
Mother with serology positive for hepatitis B surface antigen

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631800

Locations

United States, Texas
Texas Children's Hospital/Ben Taub Hospital (Baylor College of Medicine)
Houston, Texas, United States, 77030

Sponsors and Collaborators

Biosynexus Incorporated

GlaxoSmithKline

Investigators

Principal Investigator:

Leonard Weisman, MD

Baylor College of Medicine

More Information

Biosynexus Incorporated This link exits the ClinicalTrials.gov site

Responsible Party:	Biosynexus Incorporated ( Gerald Fischer, MD, President and CEO )
Study ID Numbers:	MAB-N003
Study First Received:	February 29, 2008
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00631800
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biosynexus Incorporated:

Staphylococcal
Monoclonal antibodies
Very Low Birth Weight Infants
Prophylaxis

Study placed in the following topic categories:

Antibodies, Monoclonal
Systemic Inflammatory Response Syndrome
Bacterial Infections
Body Weight
Birth Weight
Staphylococcal Infections

Antibodies
Gram-Positive Bacterial Infections
Sepsis
Bacteremia
Immunoglobulins
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 15, 2009