Clinical Trial: Compassionate Use of Stanate (TM) Stannsoporfin


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Compassionate Use of Stanate (TM) Stannsoporfin

This study is currently recruiting patients.

Sponsored by:	WellSpring Pharmaceutical Corporation
Information provided by:	WellSpring Pharmaceutical Corporation

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 and adequate clinical response to phototherapy 2)requires exchange transfusion and 3) the family refuses to allow the administration of blood products, particularly on religious grounds, such as the Jehovah's Witness Community.

Condition	Treatment or Intervention
Neonatal Jaundice 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

Further Study Details:

Expected Total Enrollment: 50

Study start: October 2003

Eligibility

Ages Eligible for Study: up to 1 Week, Genders Eligible for Study: Both

Criteria

Term or near term neonate
Elevated serum bilirubin
Failing Phototherapy
Requires Exchange Transfusion
Family refuses exahnge transfusion on religious grounds

Location and Contact Information

Benjamin Levinson, M.D. 732-938-5885 Ext. 224 blevin@wellspringpharm.com

Michigan
William Beaumont Hospital, Royal Oak, Michigan, 48073, United States; Recruiting

M. Jeffery Maisels, M.D. 248-551-0412 jmaisels@beaumont.edu

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
Record last reviewed: February 2004
Record first received: February 6, 2004
ClinicalTrials.gov Identifier: NCT00076960
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10

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