Clinical trials: Low; Birthweight
Staphylococcal Sepsis
Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110
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.
- Trial name
- N003 (NCT00631800)
- Testing
- Pagibaximab (formerly BSYX-A110)
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Biosynexus Incorporated
Neonatal Staphylococcal Sepsis
Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S.
- Trial name
- N002 (NCT00631878)
- Testing
- Pagibaximab (formerly BSYX-A110)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Biosynexus Incorporated
Staphylococcal Infections
Safety Study of an Intravenous Staphylococcus Aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates
The main objective will be to test the safety of two intravenous infusions of Altastaph, a human immunoglobulin product. The study will also test the ability of Altastaph to protect against S. aureus infection.
- Trial name
- NCT00066989
- Testing
- Staphylococcus aureus Immune Globulin (Human) 5%
- Volunteers
- 200 people
- Sponsor
- Nabi Biopharmaceuticals
Necrotizing Enterocolitis
STP206 for the Prevention of Necrotizing Enterocolitis (NEC)
This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates.
- Trial name
- NCT01954017
- Testing
- STP206, Control
- Where
- 13 sites in United States
- Volunteers
- 103 people
- Sponsor
- Leadiant Biosciences, Inc.
Staphylococcal Sepsis
Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants
The purpose of this Phase 1 study is to evaluate the safety and pharmacokinetics of BSYX-A110 in a small number of healthy adult volunteers.
- Trial name
- NCT00636285
- Testing
- BSYX-A110
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Biosynexus Incorporated
Birth Defect, Spontaneous Abortions
Nplate® Pregnancy Exposure Registry
US study to estimate the prevalence at birth of major birth defects (ie, those that cause significant functional or cosmetic impairment, require surgery, or are life-limiting) in children born to mothers who have received Nplate®…
- Conditions
- Birth Defect, Spontaneous Abortions, Low Birth Weight
- Trial name
- NPER (NCT02090088)
- Testing
- Not applicable- observational study
- Volunteers
- 4 people
- Sponsor
- Amgen