Compassionate Use of Stannsoporfin in Addition to Phototherapy to Reduce the Need for Exchange Transfusions in Term and Near-Term Infants
The purpose of this protocol is to make Stanate® (Stannsoporfin, tin-mesoporphyin) 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)requires exchange transfusion and 3) the family refuses to allow the administration of blood products, particularly on religious grounds, such as the Jehovah's Witness Community.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions in Term and Near-Term Infants|
- safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Total serum builirubin, CBC, LFTs and other safety assessments are done over the seven day period following drug administration. Adverse events are collected for 30 days.
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|