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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):
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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