Compassionate Use of Stanate (TM) [Stannsoporfin]

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InfaCare Pharmaceuticals Corporation; InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
• Treatments: Tin mesoporphyrin

Criteria

• Term or near term neonate

• Elevated serum bilirubin

• Failing phototherapy

• Requires exchange transfusion

• Family refuses exchange transfusion on religious grounds