We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Compassionate Use of Stanate (TM) [Stannsoporfin]

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00076960
First Posted: February 10, 2004
Last Update Posted: December 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
InfaCare Pharmaceuticals Corporation
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
InfaCare Pharmaceuticals Corporation
Not Provided
Not Provided
InfaCare Pharmaceuticals Corporation
January 2016