Compassionate Use of Stanate (TM) [Stannsoporfin]

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00076960
First received: February 6, 2004
Last updated: December 6, 2013
Last verified: December 2013
  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: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

Estimated Enrollment: 50
Study Start Date: October 2003
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
  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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Other Study ID Numbers: 99A
Study First Received: February 6, 2004
Last Updated: December 6, 2013
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:
Hyperbilirubinemia
Jaundice
Jaundice, Neonatal
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014