Back to resultsCompassionate Use of Stanate (TM) [Stannsoporfin]
Primary Purpose
Neonatal Jaundice, Hyperbilirubinemia
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Stanate (TM) [stannsoporfin, tin-mesoporphyrin]
Sponsored by
About this trial
This is an expanded access trial for Neonatal Jaundice focused on measuring hyperbilirubinemia, jaundice, tin-mesoporphyrin, stannsoporfin, exchange transfusion, neonatal hyperbilirubinemia
Eligibility Criteria
Term or near term neonate Elevated serum bilirubin Failing phototherapy Requires exchange transfusion Family refuses exchange transfusion on religious grounds
Sites / Locations
- William Beaumont Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00076960
First Posted
February 6, 2004
Last Updated
October 11, 2019
Sponsor
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
1. Study Identification
Unique Protocol Identification Number
NCT00076960
Brief Title
Compassionate Use of Stanate (TM) [Stannsoporfin]
Official Title
Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions
Study Type
Expanded Access
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
4. Oversight
5. Study Description
Brief Summary
The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin] available to infants who meet the following criteria:
the infant has a very high level of bilirubin without an adequate clinical response to phototherapy;
the infant requires an exchange transfusion; and
the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Jaundice, Hyperbilirubinemia
Keywords
hyperbilirubinemia, jaundice, tin-mesoporphyrin, stannsoporfin, exchange transfusion, neonatal hyperbilirubinemia
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Stanate (TM) [stannsoporfin, tin-mesoporphyrin]
Intervention Description
Treatment with 4.5 mg/kg
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Hours
Maximum Age & Unit of Time
1 Week
Accepts Healthy Volunteers
No
Eligibility Criteria
Term or near term neonate
Elevated serum bilirubin
Failing phototherapy
Requires exchange transfusion
Family refuses exchange transfusion on religious grounds
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11731664
Citation
Kappas A, Drummond GS, Munson DP, Marshall JR. Sn-Mesoporphyrin interdiction of severe hyperbilirubinemia in Jehovah's Witness newborns as an alternative to exchange transfusion. Pediatrics. 2001 Dec;108(6):1374-7. doi: 10.1542/peds.108.6.1374.
Results Reference
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Learn more about this trial
Compassionate Use of Stanate (TM) [Stannsoporfin]
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