Clinical Trial: Compassionate Use of Stanate (TM) [Stannsoporfin]
Study Status: No longer available
Recruit Status: No longer available
Study Type: Expanded Access
Official Title: 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 Summary:
Sponsor: InfaCare Pharmaceuticals Corporation
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: InfaCare Pharmaceuticals Corporation
Dates:
Date Received: February 6, 2004
Date Started: October 2003
Date Completion:
Last Updated: December 12, 2016
Last Verified: January 2016
