A Study of the Safety and Scientific Action of Stanate in Infants at Risk for Exchange Transfusion
| Status: | Archived |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
An Open-Label Study of the Safety and Clinical Pharmacology of Stanate® in Infants at-Risk for Exchange Transfusion
The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in
infants who are at risk for an exchange transfusion and meet the criteria of the protocol.
The present study will attempt to evaluate the relationship between Stanate® dose, drug
safety, efficacy and kinetics. The approach will begin with a dose of 0.75 mg/kg of birth
weight intramuscularly. This intra-muscular dose is 25% of the daily 3mg/kg dose, which was
used to study the no-effect dose during daily intravenous dosing for a total of 30 days in
adult dogs. The dose will then be increased to 1.5 mg/kg. Safety evaluations will consist of
the panel of hepatic, renal and hematologic clinical laboratory tests along with serial
physical examinations. Blood samples for Stanate® will be collected and analyzed for drug
content. Pharmacokinetic determinations will be made from a blood-level versus time curve
and urine and feces collected to determine, as far as possible, mass balance.
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