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Compassionate Use of Stanate (TM) [Stannsoporfin]

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ClinicalTrials.gov Identifier: NCT00076960
Recruitment Status : No longer available
First Posted : February 10, 2004
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):

February 6, 2004
February 10, 2004
December 13, 2016
 
Compassionate Use of Stanate (TM) [Stannsoporfin]

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
Expanded Access
Drug: Stanate (TM) [stannsoporfin, tin-mesoporphyrin]
Treatment with 4.5 mg/kg
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.
 
No longer available
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00076960
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Not Provided
Not Provided
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
January 2016