Compassionate Use of Stanate (TM) [Stannsoporfin]

This study is currently recruiting participants.

Verified by InfaCare Pharmaceuticals Corporation, February 2004

First Received: February 6, 2004 Last Updated: February 12, 2007 History of Changes

Sponsor:	InfaCare Pharmaceuticals Corporation
Information provided by:	InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:	NCT00076960

Purpose

The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin] available to infants who meet the following criteria:

the infant has a very high level of bilirubin without an adequate clinical response to phototherapy;
the infant requires an exchange transfusion; and
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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Jaundice

Drug Information available for: Tin mesoporphyrin

Further study details as provided by InfaCare Pharmaceuticals Corporation:

Estimated Enrollment:	50
Study Start Date:	October 2003

Eligibility

Criteria

Contacts and Locations

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

Contacts

Contact: Benjamin Levinson, M.D.

732-938-5885 ext 224

Locations

United States, Michigan
William Beaumont Hospital	Recruiting
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:

Study ID Numbers:	99A
Study First Received:	February 6, 2004
Last Updated:	February 12, 2007
ClinicalTrials.gov Identifier:	NCT00076960 History of Changes
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:

Signs and Symptoms
Skin Manifestations
Tin mesoporphyrin
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Hyperbilirubinemia

Infant, Newborn, Diseases
Enzyme Inhibitors
Jaundice, Neonatal
Pharmacologic Actions
Hyperbilirubinemia, Neonatal
Jaundice

ClinicalTrials.gov processed this record on November 27, 2009