FindTrial
Sign In

Compassionate Use of Stanate (TM) [Stannsoporfin]

Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00076960
Enrollment
Unknown
Registered
2004-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2019-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperbilirubinemia, Neonatal Jaundice

Keywords

hyperbilirubinemia, jaundice, tin-mesoporphyrin, stannsoporfin, exchange transfusion, neonatal hyperbilirubinemia

Brief 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.

Interventions

DRUGStanate (TM) [stannsoporfin, tin-mesoporphyrin]

Treatment with 4.5 mg/kg

Sponsors

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
12 Hours to 1 Weeks
Healthy volunteers
No

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026