NCT00631800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
Last Updated

March 10, 2008

Status Verified

February 1, 2008

Enrollment Period

10 months

First QC Date

February 29, 2008

Last Update Submit

February 29, 2008

Conditions

Staphylococcal Sepsis

Keywords

StaphylococcalMonoclonal antibodiesVery Low Birth Weight InfantsProphylaxis

Outcome Measures

Primary Outcomes (1)

  • Safety and pharmacokinetics

    0 - 56 days

Secondary Outcomes (1)

  • Pharmacodynamics, sepsis/bloodstream infection

    0 - 56 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Pagibaximab (formerly BSYX-A110)

60 mg/kg

EXPERIMENTAL

60 mg/kg was given on Days 0, 7, 14

Drug: Pagibaximab (formerly BSYX-A110)

90 mg/kg

EXPERIMENTAL

90 mg/kg was given on Days 0, 7, 14

Drug: Pagibaximab (formerly BSYX-A110)

Interventions

Pagibaximab (formerly BSYX-A110)DRUG

Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14

Also known as: BSYX-A110, HU96-110, Pagibaximab
60 mg/kg90 mg/kgPlacebo

Eligibility Criteria

Age48 Hours - 120 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Children's Hospital/Ben Taub Hospital (Baylor College of Medicine)

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 21788224DERIVED

Related Links

MeSH Terms

Interventions

pagibaximab

Study Officials

  • Leonard Weisman, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 29, 2008

First Posted

March 10, 2008

Study Start

May 1, 2003

Primary Completion

March 1, 2004

Study Completion

November 1, 2004

Last Updated

March 10, 2008

Record last verified: 2008-02

Locations

US(1)