Status:
COMPLETED
Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110
Lead Sponsor:
Biosynexus Incorporated
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Neonatal Staphylococcal Sepsis
Eligibility:
All Genders
3-7 years
Phase:
PHASE1
PHASE2
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. epid...
Detailed Description
"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-Staphy...
Eligibility Criteria
Inclusion
- Patients must meet all of the following criteria at the time of first infusion (Day 0):
- 3-7 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
Exclusion
- 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
- White Blood Count \< 2,000 cells/mm3
- 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.
- 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
- Receipt of Hepatitis B vaccine since birth
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00631878
Start Date
November 1 2001
End Date
August 1 2003
Last Update
March 10 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor College of Medicine
Houston, Texas, United States, 77030