Compassionate Use of Stanate (TM) [Stannsoporfin]

Expanded access is currently available for this treatment.
Verified January 2016 by InfaCare Pharmaceuticals Corporation
Information provided by (Responsible Party):
InfaCare Pharmaceuticals Corporation Identifier:
First received: February 6, 2004
Last updated: January 6, 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
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

Ages Eligible for Study:   up to 1 Week
Genders Eligible for Study:   Both
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
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 identifier: NCT00076960

Contact: Daniel Isaacman, M.D. 262 515 5852

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Contact: M. Jeffery Maisels, M.D.    248-551-0412   
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: January 6, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by InfaCare Pharmaceuticals Corporation:
exchange transfusion
neonatal hyperbilirubinemia

Additional relevant MeSH terms:
Jaundice, Neonatal
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 26, 2016