Compassionate Use of Stanate (TM) [Stannsoporfin]

InfaCare Pharmaceuticals Corporation

Status

Conditions: Hyperbilirubinemia; Neonatal Jaundice

Treatments: Drug: Stanate (TM) [stannsoporfin, tin-mesoporphyrin]

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00076960

99A

Details and patient eligibility

About

The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin] available to infants who meet the following criteria:

1. the infant has a very high level of bilirubin without an adequate clinical response to phototherapy;
2. the infant requires an exchange transfusion; and
3. the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.

Sex: All

Ages: 12 hours to 1 week old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Term or near term neonate
• Elevated serum bilirubin
• Failing phototherapy
• Requires exchange transfusion
• Family refuses exchange transfusion on religious grounds