Compassionate Use of Stanate (TM) [Stannsoporfin]

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00076960
First received: February 6, 2004
Last updated: December 6, 2013
Last verified: December 2013

February 6, 2004
December 6, 2013
October 2003
July 2017   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00076960 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Compassionate Use of Stanate (TM) [Stannsoporfin]
Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions

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 an adequate clinical response to phototherapy;
  2. the infant requires an exchange transfusion; and
  3. the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neonatal Jaundice
  • Hyperbilirubinemia
Drug: Stanate (TM) [stannsoporfin, tin-mesoporphyrin]
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
Not Provided
July 2017   (final data collection date for primary outcome measure)
  • Term or near term neonate
  • Elevated serum bilirubin
  • Failing phototherapy
  • Requires exchange transfusion
  • Family refuses exchange transfusion on religious grounds
Both
up to 1 Week
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00076960
99A
Not Provided
InfaCare Pharmaceuticals Corporation
InfaCare Pharmaceuticals Corporation
Not Provided
Not Provided
InfaCare Pharmaceuticals Corporation
December 2013

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