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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: Completed Phase 2 study of Staphylococcal Sepsis, sponsored by Biosynexus Incorporated.
NCT00646399 is a Phase 2 study of Staphylococcal Sepsis that has completed, run by Biosynexus Incorporated. The registered enrollment target is 1,579 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1087% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety and efficacy
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 |
What the finished NCT00646399 record still lists
NCT00646399 is an interventional study that assigns participants to a tested intervention. Its 1,579 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1087% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00646399's enrollment target sits among peer trials
1,579 11th of 2000 higher than 1,990 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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