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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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 Comparator: Placebo
Placebo
Drug: Pagibaximab (formerly BSYX-A110)
Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14
Other Names:
  • BSYX-A110
  • HU96-110
  • Pagibaximab
Experimental: 60 mg/kg
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
Other Names:
  • BSYX-A110
  • HU96-110
  • Pagibaximab
Experimental: 90 mg/kg
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
Other Names:
  • BSYX-A110
  • HU96-110
  • Pagibaximab

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):

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Biosynexus Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerald Fischer, MD, President and CEO, Biosynexus Incorporated
ClinicalTrials.gov Identifier: NCT00631800     History of Changes
Other Study ID Numbers: MAB-N003
Study First Received: February 29, 2008
Last Updated: February 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Biosynexus Incorporated:
Staphylococcal
Monoclonal antibodies
Very Low Birth Weight Infants
Prophylaxis

Additional relevant MeSH terms:
Sepsis
Staphylococcal Infections
Bacteremia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 24, 2014