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Compassionate Use of Stanate (TM) [Stannsoporfin]

Expanded access is currently available for this treatment.
Verified May 2014 by InfaCare Pharmaceuticals Corporation
Sponsor:
Information provided by (Responsible Party):
InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00076960
First received: February 6, 2004
Last updated: May 28, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   up to 1 Week
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076960

Contacts
Contact: Daniel Isaacman, M.D. 262 515 5852 disaacman@infacare.com

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Contact: M. Jeffery Maisels, M.D.    248-551-0412    jmaisels@beaumont.edu   
Sponsors and Collaborators
InfaCare Pharmaceuticals Corporation
  More Information

Publications:
Responsible Party: InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00076960     History of Changes
Other Study ID Numbers: 99A
Study First Received: February 6, 2004
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 24, 2014