Compassionate Use of Stanate (TM) [Stannsoporfin] - Full Text View

Compassionate Use of Stanate (TM) [Stannsoporfin]

This study is currently recruiting participants.
Verified by InfaCare Pharmaceuticals Corporation, February 2004

Sponsored by:	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]

MedlinePlus related topics:

Blood Transfusion and Donation Jaundice

Drug Information available for:

Tin mesoporphyrin

U.S. FDA Resources

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

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.

Study ID Numbers:	99A
First Received:	February 6, 2004
Last Updated:	February 12, 2007
ClinicalTrials.gov Identifier:	NCT00076960
Health Authority:	United States: Food and Drug Administration

Keywords provided by InfaCare Pharmaceuticals Corporation:

hyperbilirubinemia

jaundice

tin-mesoporphyrin

stannsoporfin

exchange transfusion

neonatal hyperbilirubinemia

Study placed in the following topic categories:

Signs and Symptoms

Tin mesoporphyrin

Hyperbilirubinemia

Infant, Newborn, Diseases

Jaundice, Neonatal

Jaundice

Hyperbilirubinemia, Neonatal

Additional relevant MeSH terms:

Skin Manifestations

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008