Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115544
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2005-06-22
Brief Title:
Safety and Pharmacology of Stanate
Sponsor:
InfaCare Pharmaceuticals Corporation a Mallinckrodt Company
Organization:
Mallinckrodt
Study Overview
Official Title:
An Open-Label Study of the Safety and Clinical Pharmacology of Stanate in Infants At-Risk for Exchange Transfusion
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect and safety of Stanate stannsoporfin in infants who are at risk for an exchange transfusion and meet the criteria of the protocol
Detailed Description:
The present study evaluated the relationship between Stanate dose drug safety and efficacy in a non randomised sequential open label cohort design in 55 patients Subjects were term and near term infants at medium or high risk of hyperbilirubinemia with TSB levels approaching the threshold for exchange transfusion The first cohort began at a dose of stannsoporfin 075 mgkg of birth weight intramuscularly The dose was then increased to 15 mgkg for cohort 2 and saline was given placebo for cohort 3 Safety evaluations consisted of hepatic renal and hematologic clinical laboratory tests along with serial physical examinations Long term follow up of all patients to age 6 is planned
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| no grant or contracts | None | None | None |