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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2016-05-10

Brief Summary

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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".

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Detailed Description

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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

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Hyperbilirubinemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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0.75 mg/kg Previous exposure to stannsoporfin

Previous exposure 0.75 mg/kg

Previous exposure to stannsoporfin

Intervention Type OTHER

No intervention in this protocol

1.5 mg/kg Previous exposure to stannsoporfin

Previous exposure 1.5 mg/kg

Previous exposure to stannsoporfin

Intervention Type OTHER

No intervention in this protocol

Interventions

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Previous exposure to stannsoporfin

No intervention in this protocol

Intervention Type OTHER

Eligibility Criteria

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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.