drugset / Trial / NCT02685137
Efficacy and Safety of Stannsoporfin in Neonates
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the well-baby nursery and enrolled with "intention to treat".
Timeline
- Start
- 2002-05-01
- Primary completion
- 2003-03-16
- Completion
- 2013-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | stannsoporfin | Small molecule | 4.5 mg/kg | Intramuscular |