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

Tracking Information

First Received Date ^ICMJE

February 6, 2004

Last Updated Date

February 12, 2007

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00076960 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Compassionate Use of Stanate (TM) [Stannsoporfin]

Official Title ^ICMJE

Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Neonatal Jaundice
Hyperbilirubinemia

Intervention ^ICMJE

Drug: Stanate (TM) [stannsoporfin, tin-mesoporphyrin]

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Term or near term neonate
Elevated serum bilirubin
Failing phototherapy
Requires exchange transfusion
Family refuses exchange transfusion on religious grounds

Gender

Both

Ages

up to 1 Week

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Benjamin Levinson, M.D.

732-938-5885 ext 224

blevin@wellspringpharm.com

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00076960

Responsible Party

Study ID Numbers ^ICMJE

99A

Study Sponsor ^ICMJE

InfaCare Pharmaceuticals Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

InfaCare Pharmaceuticals Corporation

Verification Date

February 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP