Suspended

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

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What is being tested

Data Collection

Who is eligible

Hyperbilirubinemia
+4

+ Infant, Newborn, Diseases
+ Jaundice
See all eligibility criteria
How is it accessible

Suspended

Available upon a request by a licensed MD
Expanded Access
See protocol details

Summary

Principal SponsorInfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleCompassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions 
NCT01183988NCT00076960
Principal SponsorInfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Range of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hyperbilirubinemia
Infant, Newborn, Diseases
Jaundice
Jaundice, Neonatal
Pathologic Processes
Skin Manifestations
Hyperbilirubinemia, Neonatal
Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
William Beaumont HospitalRoyal Oak, United StatesSee the location
SuspendedOne Study Center