NCT02685189

Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)

Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)(WS)(ISNHP)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 55 (estimated)
• Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company · Industry
• Sex: All
• Age: 1 Day – 60 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion".

Detailed description

The purpose of this protocol is to provide a mechanism to collect Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion". Data on long-term impact of Stannsoporfin on the physical, neurological, neurodevelopmental, biochemical, metabolic and hematopoietic profiles of the children will be collected at 9 and 18 months, 3, 6 and 9 years after Stannsoporfin administration

Conditions

• Hyperbilirubinemia

Interventions

Type	Name	Description
OTHER	Previous exposure to stannsoporfin	No intervention in this protocol

Timeline

• Start date: 2006-07-01
• Primary completion: 2016-05-10
• Completion: 2016-05-10
• First posted: 2016-02-18
• Last updated: 2019-10-15