Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110 (N003)
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ClinicalTrials.gov Identifier: NCT00631800 |
Recruitment Status
:
Completed
First Posted
: March 10, 2008
Last Update Posted
: March 10, 2008
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Sponsor:
Biosynexus Incorporated
Collaborator:
GlaxoSmithKline
Information provided by:
Biosynexus Incorporated
Tracking Information | ||||
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First Submitted Date ICMJE | February 29, 2008 | |||
First Posted Date ICMJE | March 10, 2008 | |||
Last Update Posted Date | March 10, 2008 | |||
Study Start Date ICMJE | May 2003 | |||
Actual Primary Completion Date | March 2004 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Safety and pharmacokinetics [ Time Frame: 0 - 56 days ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
Pharmacodynamics, sepsis/bloodstream infection [ Time Frame: 0 - 56 days ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110 | |||
Official Title ICMJE | Phase II Randomized, Double Blind, Placebo Controlled, Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110, for the Prevention of Staphylococcal Infection | |||
Brief Summary | The purpose of this study is to evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a 3-dose regimen on Study Days 0, 7, and 14. | |||
Detailed Description | This Phase II study will be a randomized, double blind, placebo controlled study of BSYX-A110 in very low birth weight neonates. A total of 80 infants will be dosed in this study. Participants will receive either BSYX-A110 or placebo, at 60 mg/kg or 90 mg/kg. The Study Drug will be administered at 48-120 hours of life, 7 days after the initial dose, and 14 days after the initial dose for all dose groups. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Staphylococcal Sepsis | |||
Intervention ICMJE | Drug: Pagibaximab (formerly BSYX-A110)
Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14
Other Names:
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Study Arms |
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Publications * | Weisman LE, Thackray HM, Steinhorn RH, Walsh WF, Lassiter HA, Dhanireddy R, Brozanski BS, Palmer KG, Trautman MS, Escobedo M, Meissner HC, Sasidharan P, Fretz J, Kokai-Kun JF, Kramer WG, Fischer GW, Mond JJ. A randomized study of a monoclonal antibody (pagibaximab) to prevent staphylococcal sepsis. Pediatrics. 2011 Aug;128(2):271-9. doi: 10.1542/peds.2010-3081. Epub 2011 Jul 25. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
88 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | November 2004 | |||
Actual Primary Completion Date | March 2004 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | 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 the first dose:
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Sex/Gender |
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Ages | up to 120 Hours (Child) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00631800 | |||
Other Study ID Numbers ICMJE | MAB-N003 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Gerald Fischer, MD, President and CEO, Biosynexus Incorporated | |||
Study Sponsor ICMJE | Biosynexus Incorporated | |||
Collaborators ICMJE | GlaxoSmithKline | |||
Investigators ICMJE |
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PRS Account | Biosynexus Incorporated | |||
Verification Date | February 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |