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Sponsors and Collaborators: |
Biosynexus Incorporated GlaxoSmithKline |
Information provided by: | Biosynexus Incorporated |
ClinicalTrials.gov Identifier: | NCT00631878 |
"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.
Condition | Intervention | Phase |
Neonatal Staphylococcal Sepsis |
Drug: Pagibaximab (formerly BSYX-A110) |
Phase I Phase II |
MedlinePlus related topics: | Sepsis |
Drug Information available for: | Pagibaximab |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Randomized, Double Blind, Placebo Controlled, Dose Escalation, Safety and Pharmacokinetics Study in VLBW Neonates, a Human Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. Epidermidis Infection |
Enrollment: | 53 |
Study Start Date: | November 2001 |
Study Completion Date: | August 2003 |
Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Placebo: Placebo Comparator |
Drug: Pagibaximab (formerly BSYX-A110)
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
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10 mg/kg: Experimental
10 mg/kg was given on Days 0, 14
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Drug: Pagibaximab (formerly BSYX-A110)
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
|
30 mg/kg: Experimental
30 mg/kg was given on Days 0, 14
|
Drug: Pagibaximab (formerly BSYX-A110)
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
|
60 mg/kg: Experimental
60 mg/kg was given on Days 0, 14
|
Drug: Pagibaximab (formerly BSYX-A110)
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
|
90 mg/kg: Experimental
90 mg/kg was given on Days 0, 14
|
Drug: Pagibaximab (formerly BSYX-A110)
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
|
"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, a Human Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. epidermidis Infection" will be the first study of BSYX-A110 in the target population of hospitalized, very low birth weight infants. 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.
This will be a randomized, double blind, placebo controlled, dose escalating study of BSYX-A110 in 48 very low birth weight neonates. The dose levels to be evaluated are 10, 30, 60 and 90 mg/kg. Each dose level will enroll 12 infants who will receive two doses of BSYX-A110 or placebo intravenously at a ratio of 2:1 while hospitalized following birth. Infants will be followed for 8 weeks following the first dose of BSYX-A110 or placebo. The primary objective of this study is to evaluate safety and tolerability. The secondary objective is to analyze the pharmacokinetics of BSYX-A110. Positive cultures obtained during the study period will be recorded and analyzed.
Ages Eligible for Study: | up to 7 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must meet all of the following criteria at the time of first infusion (Day 0):
Multiple gestations:
Exclusion Criteria:
Patients may have none of the following at either the first or second dose:
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
Any of the following laboratory findings
United States, Texas | |||||
Baylor College of Medicine | |||||
Houston, Texas, United States, 77030 |
Biosynexus Incorporated |
GlaxoSmithKline |
Principal Investigator: | Leonard Weisman, MD | Baylor College of Medicine |
Biosynexus Incorporated 
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Responsible Party: | Biosyneuxs Incorporated ( Gerald Fischer, MD, President and CEO ) |
Study ID Numbers: | MAB-N002 |
First Received: | February 29, 2008 |
Last Updated: | February 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00631878 |
Health Authority: | United States: Food and Drug Administration |
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