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

Terminated

• Conditions: Hyperbilirubinemia
• Interventions: Other: Previous exposure to stannsoporfin

• Registration Number: NCT02685189
• Lead Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Brief 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

Study Timeline

• Study Start: 2006-07
• Status Verified: 2016-02
• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-18
• Primary Completion: 2016-05-10
• Study Completion: 2016-05-10
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• All children who have been enrolled and received Stanate® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
0.75 mg/kg Previous exposure to stannsoporfin	Previous exposure to stannsoporfin	Previous exposure 0.75 mg/kg
1.5 mg/kg Previous exposure to stannsoporfin	Previous exposure to stannsoporfin	Previous exposure 1.5 mg/kg

Primary Outcome Measures

Name	Time	Method
NEUROLOGICAL EXAMINATION; Child Behavior Check List	10 years	Child Behavior Check List is a standardized measure in child psychology for evaluating maladaptive behavioral and emotional problems in preschool patients