NCT00631878

Brief Summary

"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S. epidermidis Infection." The purpose of this study is to evaluate the safety and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2001

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

November 1, 2001

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
4.6 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

1.5 years

First QC Date

February 29, 2008

Last Update Submit

February 29, 2008

Conditions

Neonatal Staphylococcal Sepsis

Keywords

StaphylococcalMonoclonal antibodiesVery Low Birth Weight InfantsProphylaxis

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability.

    0 - 52 days

Secondary Outcomes (1)

  • Evaluate the pharmacokinetics and positive cultures.

    0 - 52 days

Study Arms (5)

Placebo

PLACEBO COMPARATOR
Drug: Pagibaximab (formerly BSYX-A110)

10 mg/kg

EXPERIMENTAL

10 mg/kg was given on Days 0, 14

Drug: Pagibaximab (formerly BSYX-A110)

30 mg/kg

EXPERIMENTAL

30 mg/kg was given on Days 0, 14

Drug: Pagibaximab (formerly BSYX-A110)

60 mg/kg

EXPERIMENTAL

60 mg/kg was given on Days 0, 14

Drug: Pagibaximab (formerly BSYX-A110)

90 mg/kg

EXPERIMENTAL

90 mg/kg was given on Days 0, 14

Drug: Pagibaximab (formerly BSYX-A110)

Interventions

Pagibaximab (formerly BSYX-A110)DRUG

Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.

Also known as: BSYX-A110, HU96-110, Pagibaximab
10 mg/kg30 mg/kg60 mg/kg90 mg/kgPlacebo

Eligibility Criteria

Age3 Days - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients must meet all of the following criteria at the time of first infusion (Day 0):
  • days of age, inclusive
  • Birth weight of 700-1300 grams
  • Survival expected for at least 1 week after infusion
  • Inpatient in a Neonatal Intensive Care Unit with intravenous access
  • Written informed consent obtained from the parent(s) or 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 or dose cohort may be siblings

You may not qualify if:

  • Patients may have none of the following at either the first or second dose:
  • Clinically overt systemic infection, as determined by history, physical examination, culture or laboratory data. Neonates with known or suspected HIV infection but without other active systemic infection are not excluded.
  • Life threatening hemodynamic instability
  • Severe congenital anomalies or genetic disorders (especially any predisposing to cardiac decompensation) 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
  • Persistent seizure disorder
  • Immunodeficiency other than due to prematurity
  • A history of immune globulin administration prior to first study drug infusion
  • Any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin G, or blood products.
  • Any of the following laboratory findings
  • BUN or creatinine \> 1.5 x upper limit of normal for age
  • AST (SGOT), ALT (SGPT) or total bilirubin \> 1.5 x upper limit of normal age
  • Direct bilirubin of \> 2.0 mg/dL
  • Hemoglobin \< 9.0gm/dL
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

pagibaximab

Study Officials

  • Leonard Weisman, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
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

November 1, 2001

Primary Completion

May 1, 2003

Study Completion

August 1, 2003

Last Updated

March 10, 2008

Record last verified: 2008-02

Locations

US(1)