Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110
NCT ID: NCT00631878
Last Updated: 2008-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
53 participants
INTERVENTIONAL
2001-11-30
2003-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo
Pagibaximab (formerly BSYX-A110)
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
10 mg/kg
10 mg/kg was given on Days 0, 14
Pagibaximab (formerly BSYX-A110)
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
30 mg/kg
30 mg/kg was given on Days 0, 14
Pagibaximab (formerly BSYX-A110)
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
60 mg/kg
60 mg/kg was given on Days 0, 14
Pagibaximab (formerly BSYX-A110)
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
90 mg/kg
90 mg/kg was given on Days 0, 14
Pagibaximab (formerly BSYX-A110)
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
Interventions
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Pagibaximab (formerly BSYX-A110)
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. 3-7 days of age, inclusive
2. Birth weight of 700-1300 grams
3. Survival expected for at least 1 week after infusion
4. Inpatient in a Neonatal Intensive Care Unit with intravenous access
5. Written informed consent obtained from the parent(s) or 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 or dose cohort may be siblings
Exclusion Criteria
1. 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.
2. Life threatening hemodynamic instability
3. 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
4. Known or suspected hepatic or renal insufficiency
5. Persistent seizure disorder
6. Immunodeficiency other than due to prematurity
7. A history of immune globulin administration prior to first study drug infusion
8. Any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin G, or blood products.
9. Any of the following laboratory findings
1. BUN or creatinine \> 1.5 x upper limit of normal for age
2. AST (SGOT), ALT (SGPT) or total bilirubin \> 1.5 x upper limit of normal age
3. Direct bilirubin of \> 2.0 mg/dL
4. Hemoglobin \< 9.0gm/dL
5. White Blood Count \< 2,000 cells/mm3
10. Currently receiving or recently received other investigational agents that could interfere with conduct or results of this study. Each patient receiving other investigational agents will be reviewed by the investigator or his designee with the Sponsor prior to the patient's entry into the study.
11. Expectation that the patient will not be able to be followed for the duration of the study.
12. Mother with serology positive for hepatitis B surface antigen
13. Receipt of Hepatitis B vaccine since birth
3 Days
7 Days
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Biosynexus Incorporated
INDUSTRY
Responsible Party
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Biosyneuxs Incorporated
Principal Investigators
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Leonard Weisman, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Baylor College of Medicine
Houston, Texas, United States
Countries
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Related Links
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Biosynexus Incorporated
Other Identifiers
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MAB-N002
Identifier Type: -
Identifier Source: org_study_id
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