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Compassionate Use of Stanate (TM) [Stannsoporfin]

NCT00076960 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2019-10-15

No results posted yet for this study

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.

Conditions

  • Neonatal Jaundice
  • Hyperbilirubinemia

Interventions

DRUG

Stanate (TM) [stannsoporfin, tin-mesoporphyrin]

Treatment with 4.5 mg/kg

Sponsors & Collaborators

  • InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

    lead INDUSTRY

Eligibility

Min Age
12 Hours
Max Age
1 Week
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00076960 on ClinicalTrials.gov