Suspended
Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions
What is being tested
Data Collection
Who is eligible
Hyperbilirubinemia+7
+ Infant, Newborn, Diseases
+ Jaundice
How is it accessible
Suspended
Available upon a request by a licensed MDExpanded Access
Summary
Principal SponsorInfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Last updated: January 28, 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
Principal SponsorInfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Last updated: January 28, 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 sex
Biological sex of participants that are eligible to enroll.Range of ages for which participants are eligible to join.
Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
HyperbilirubinemiaInfant, Newborn, DiseasesJaundiceJaundice, NeonatalCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesSigns and SymptomsSkin ManifestationsPathological Conditions, Signs and SymptomsHyperbilirubinemia, 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
SuspendedOne Study Center