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Compassionate Use of Stanate (TM) [Stannsoporfin]

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00076960
First Posted: February 10, 2004
Last Update Posted: December 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
InfaCare Pharmaceuticals Corporation
  Purpose

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Term or near term neonate
  • Elevated serum bilirubin
  • Failing phototherapy
  • Requires exchange transfusion
  • Family refuses exchange transfusion on religious grounds
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076960


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

Publications:
Responsible Party: InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00076960     History of Changes
Obsolete Identifiers: NCT01183988
Other Study ID Numbers: 99A
First Submitted: February 6, 2004
First Posted: February 10, 2004
Last Update Posted: December 13, 2016
Last Verified: January 2016

Keywords provided by InfaCare Pharmaceuticals Corporation:
hyperbilirubinemia
jaundice
tin-mesoporphyrin
stannsoporfin
exchange transfusion
neonatal hyperbilirubinemia

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