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Compassionate Use of Stanate (TM) [Stannsoporfin]

Expanded access is no longer available for this treatment.
Information provided by (Responsible Party):
InfaCare Pharmaceuticals Corporation Identifier:
First received: February 6, 2004
Last updated: December 12, 2016
Last verified: January 2016

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.

Condition Intervention
Neonatal Jaundice Hyperbilirubinemia Drug: Stanate (TM) [stannsoporfin, tin-mesoporphyrin]

Study Type: Expanded Access     What is Expanded Access?
Official Title: Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions

Further study details as provided by InfaCare Pharmaceuticals Corporation:

Study Start Date: October 2003
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Stanate (TM) [stannsoporfin, tin-mesoporphyrin]
    Treatment with 4.5 mg/kg

Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Term or near term neonate
  • Elevated serum bilirubin
  • Failing phototherapy
  • Requires exchange transfusion
  • Family refuses exchange transfusion on religious grounds
  Contacts and Locations
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Please refer to this study by its identifier: NCT00076960

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
InfaCare Pharmaceuticals Corporation
  More Information

Responsible Party: InfaCare Pharmaceuticals Corporation Identifier: NCT00076960     History of Changes
Obsolete Identifiers: NCT01183988
Other Study ID Numbers: 99A
Study First Received: February 6, 2004
Last Updated: December 12, 2016

Keywords provided by InfaCare Pharmaceuticals Corporation:
exchange transfusion
neonatal hyperbilirubinemia

Additional relevant MeSH terms:
Jaundice, Neonatal
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017