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| Sponsored by: |
Biosynexus Incorporated |
| Information provided by: | Biosynexus Incorporated |
| ClinicalTrials.gov Identifier: | NCT00646399 |
Purpose
The purpose of this study is to evaluate the safety, efficacy, and PK comparing Pagibaximab Injection to placebo. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23.
| Condition | Intervention | Phase |
|
Staphylococcal Sepsis |
Drug: Pagibaximab (formerly BSYX-A110) |
Phase II Phase III |
| MedlinePlus related topics: | Sepsis |
| ChemIDplus related topics: | Pagibaximab |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight (VLBW) Neonates for the Prevention of Staphylococcal Sepsis |
| Estimated Enrollment: | 1550 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
Placebo: Placebo Comparator
Placebo
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Drug: Pagibaximab (formerly BSYX-A110)
Dosed on Days 0, 1, 2, 9, 16 and 23.
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100 mg/kg: Experimental
Pagibaximab at 100 mg/kg intravenously at Days 0, 1, 2, 9, 16 and 23.
|
Drug: Pagibaximab (formerly BSYX-A110)
Pagibaximab at 100 mg/kg intravenously on Days 0, 1, 2, 9, 16 and 23
|
This is a Phase 2b/3, randomized, double-blind, multicenter, placebo-controlled study evaluating the safety, efficacy and pharmacokinetics (PK) of pagibaximab (100 mg/kg/dose) in comparison to placebo for the prevention of staphylococcal sepsis in VLBW infants (600 -1200 grams). Subjects monitored for treatment related adverse events and tolerability to infusion of study drug. Neonatal sepsis will be assessed in the presence of clinical signs and symptoms and one blood culture positive for S. aureus or two blood cultures positive for Coagulase Negative Staphylococci (CoNS). The study period will be 35 days after the first dose or until, death, discharge, or transfer, whichever occurs first.
Eligibility
| Ages Eligible for Study: | up to 48 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
For multiple gestations, twins may be enrolled if they each meet the entry criteria. They will both be assigned to the same treatment group.
Exclusion Criteria:
Contacts and Locations| Contact: John Kokai-Kun, PhD | 301-330-5800 ext 1172 | johnkun@biosynexus.com |
| Contact: Jimmy Mond, MD | 301-330-5800 ext 1161 | jimmymond@biosynexus.com |
| United States, Maryland | |||||
| Biosynexus Incorporated | Not yet recruiting | ||||
| Gaithersburg, Maryland, United States, 20877 | |||||
| Contact: John Kokai-Kun, PhD 301-330-5800 ext 1172 johnkun@biosynexus.com | |||||
| Biosynexus Incorporated |
More Information
Biosynexus Incorporated 
  |
| Responsible Party: | Biosynexus Incorporated ( Irwin Scher, President and CEO ) |
| Study ID Numbers: | MAB-N007 |
| First Received: | March 26, 2008 |
| Last Updated: | October 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00646399 |
| Health Authority: | United States: Food and Drug Administration |
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