Compassionate Use of Stanate (TM) [Stannsoporfin]

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2004 by InfaCare Pharmaceuticals Corporation. Recruitment status was Recruiting

First Received on February 6, 2004. Last Updated on 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:	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:

MedlinePlus related topics: Blood Transfusion and Donation Jaundice

Drug Information available for: Tin mesoporphyrin

U.S. FDA Resources

Further study details as provided by InfaCare Pharmaceuticals Corporation:

Estimated Enrollment:	50
Study Start Date:	October 2003

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

Contacts

Contact: Benjamin Levinson, M.D.

732-938-5885 ext 224

blevin@wellspringpharm.com

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:

Kappas A, Drummond GS, Munson DP, Marshall JR. Sn-Mesoporphyrin interdiction of severe hyperbilirubinemia in Jehovah's Witness newborns as an alternative to exchange transfusion. Pediatrics. 2001 Dec;108(6):1374-7.

ClinicalTrials.gov Identifier:	NCT00076960 History of Changes
Other Study ID Numbers:	99A
Study First Received:	February 6, 2004
Last Updated:	February 12, 2007
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 February 09, 2012