Status:
COMPLETED
Safety and Pharmacology of Stanate
Lead Sponsor:
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Collaborating Sponsors:
National Children's Hospital, Vietnam
Conditions:
Hyperbilirubinemia
Eligibility:
All Genders
2-7 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Term and near-term healthy infants (may be no more than 14 days of age) with excessive hyperbilirubinemia who are at risk for exchange transfusion according to the AAP guidelines of 2004
Exclusion
- No parental consent
- Major known congenital anomaly
- Current use of antibiotics, cardio-respiratory instability, abnormal renal function, hepatitis (as related to TORCH infections)
- Phenobarbital use in either child or mother (30 days prior to child's birth)
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00115544
Start Date
September 1 2005
End Date
July 1 2006
Last Update
October 15 2019
Active Locations (1)
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1
National hospital of pediatrics
Hanoi, Vietnam