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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Biosynexus Incorporated
ClinicalTrials.gov Identifier:
NCT00631800
First received: February 29, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted

February 29, 2008
February 29, 2008
May 2003
March 2004   (final data collection date for primary outcome measure)
Safety and pharmacokinetics [ Time Frame: 0 - 56 days ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Pharmacodynamics, sepsis/bloodstream infection [ Time Frame: 0 - 56 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Staphylococcal Sepsis
Drug: Pagibaximab (formerly BSYX-A110)
Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14
Other Names:
  • BSYX-A110
  • HU96-110
  • Pagibaximab
  • 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)
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. Epub 2011 Jul 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
November 2004
March 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

  1. 48-120 hours of age, inclusive
  2. Birth weight of 700-1300 grams
  3. Inpatient in a Neonatal Intensive Care Unit
  4. Written informed consent obtained from the parent(s) or legal guardian

Multiple gestations:

  1. Siblings from multiple gestations may be enrolled if they each meet the entry criteria
  2. 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:

  1. Survival not expected for at least 1 week after infusion
  2. 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.)
  3. 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

  4. Known or suspected hepatic or renal insufficiency
  5. Clinically uncontrolled seizures
  6. Immunodeficiency other than due to prematurity
  7. A history of standard immune globulin administration prior to first study drug infusion (excluding Hepatitis B Immune Globulin, HBIG)
  8. Any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin G, or blood products
  9. 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
  10. Expectation that the patient will not be able to be followed for the duration of the study
  11. Mother with serology positive for hepatitis B surface antigen
Both
up to 120 Hours
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00631800
MAB-N003
Yes
Gerald Fischer, MD, President and CEO, Biosynexus Incorporated
Biosynexus Incorporated
GlaxoSmithKline
Principal Investigator: Leonard Weisman, MD Baylor College of Medicine
Biosynexus Incorporated
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP