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NCT00646399 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
A Phase 2 study of Staphylococcal Sepsis, sponsored by Biosynexus Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,579
- Enrollment target
- 1
- Study location
NCT00646399 is a Phase 2 study of Staphylococcal Sepsis that has completed, run by Biosynexus Incorporated. The registered enrollment target is 1,579 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00646399, a Phase 2 study of Staphylococcal Sepsis, has completed, sponsored by Biosynexus Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,579 participants
- Enrollment target
- 1
- Study location
Study Summary
Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pagibaximab 50 mg/mL
Study Locations (1)
Maryland
- Biosynexus Incorporated - Gaithersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,579 participants |
| Start Date | 2009-03 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00646399
The ClinicalTrials.gov registry entry for NCT00646399 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,579 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biosynexus Incorporated, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Staphylococcal Sepsis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00646399 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00646399 about?
NCT00646399 is a clinical study titled "Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis". Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 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...
What is the current status of trial NCT00646399?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,579 participants. The study started on 2009-03. Estimated completion is 2011-05.
What conditions does trial NCT00646399 study?
This clinical trial studies the following conditions: Staphylococcal Sepsis.
What interventions are being tested in trial NCT00646399?
The interventions under investigation include: Placebo (DRUG), Pagibaximab 50 mg/mL (DRUG).
Who is sponsoring clinical trial NCT00646399?
This trial is sponsored by Biosynexus Incorporated, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00646399 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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