Safety and Pharmacology of Stanate

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InfaCare Pharmaceuticals Corporation; InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
• Collaborators: National Children's Hospital, Vietnam; National Hospital of Pediatrics, Vietnam
• Treatments: Tin mesoporphyrin

Criteria

Inclusion Criteria:

• Term and near-term healthy infants (may be no more than 14 days of age) with excessive hyperbilirubinemia who are at risk for exchange transfusion according to the AAP guidelines of 2004

Exclusion Criteria:

• No parental consent

• Major known congenital anomaly

• Current use of antibiotics, cardio-respiratory instability, abnormal renal function, hepatitis (as related to TORCH infections)

• Phenobarbital use in either child or mother (30 days prior to child's birth)