Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

1,579

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Staphylococcal Sepsis
Interventions
DRUG

Placebo

Phosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23.

DRUG

Pagibaximab 50 mg/mL

Pagibaximab 100 mg/kg dosed on Days 0, 1, 2, 9, 16 and 23

Trial Locations (1)

20877

Biosynexus Incorporated, Gaithersburg

Sponsors
All Listed Sponsors
lead

Biosynexus Incorporated

INDUSTRY

NCT00646399 - Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis | Biotech Hunter | Biotech Hunter