Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076960
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-10-15
First Post:
2004-02-06
Brief Title:
Compassionate Use of Stanate TM Stannsoporfin
Sponsor:
InfaCare Pharmaceuticals Corporation a Mallinckrodt Company
Organization:
Mallinckrodt
Study Overview
Official Title:
Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Jehovahs Witness community
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 Jehovahs Witness community
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None