Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110 (N003)

Tracking Information
First Submitted Date ICMJE	February 29, 2008
First Posted Date ICMJE	March 10, 2008
Last Update Posted Date	March 10, 2008
Study Start Date ICMJE	May 2003
Actual Primary Completion Date	March 2004 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 29, 2008)	Safety and pharmacokinetics [ Time Frame: 0 - 56 days ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: February 29, 2008)	Pharmacodynamics, sepsis/bloodstream infection [ Time Frame: 0 - 56 days ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110
Official Title ICMJE	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
Brief Summary	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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
Condition ICMJE	Staphylococcal Sepsis
Intervention ICMJE	Drug: Pagibaximab (formerly BSYX-A110); Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14; Other Names: BSYX-A110; HU96-110; Pagibaximab
Study Arms	Placebo Comparator: Placebo Placebo Intervention: Drug: Pagibaximab (formerly BSYX-A110); Experimental: 60 mg/kg 60 mg/kg was given on Days 0, 7, 14 Intervention: Drug: Pagibaximab (formerly BSYX-A110); Experimental: 90 mg/kg 90 mg/kg was given on Days 0, 7, 14 Intervention: Drug: Pagibaximab (formerly BSYX-A110)
Publications *	Weisman LE, Thackray HM, Steinhorn RH, Walsh WF, Lassiter HA, Dhanireddy R, Brozanski BS, Palmer KG, Trautman MS, Escobedo M, Meissner HC, Sasidharan P, Fretz J, Kokai-Kun JF, Kramer WG, Fischer GW, Mond JJ. A randomized study of a monoclonal antibody (pagibaximab) to prevent staphylococcal sepsis. Pediatrics. 2011 Aug;128(2):271-9. doi: 10.1542/peds.2010-3081. Epub 2011 Jul 25.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 29, 2008)	88
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	November 2004
Actual Primary Completion Date	March 2004 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 120 Hours (Child)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00631800
Other Study ID Numbers ICMJE	MAB-N003
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Gerald Fischer, MD, President and CEO, Biosynexus Incorporated
Study Sponsor ICMJE	Biosynexus Incorporated
Collaborators ICMJE	GlaxoSmithKline
Investigators ICMJE	Principal Investigator: Leonard Weisman, MD Baylor College of Medicine
PRS Account	Biosynexus Incorporated
Verification Date	February 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP