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)

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".

Study Overview

• Status: Terminated
• Conditions: Hyperbilirubinemia
• Intervention / Treatment: Other: Previous exposure to stannsoporfin

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 Type: Observational
• Enrollment (Anticipated): 55

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
0.75 mg/kg Previous exposure to stannsoporfin; Previous exposure 0.75 mg/kg	Other: Previous exposure to stannsoporfin; No intervention in this protocol
1.5 mg/kg Previous exposure to stannsoporfin; Previous exposure 1.5 mg/kg	Other: Previous exposure to stannsoporfin; No intervention in this protocol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
• Investigators: Study Director: Nancy Ruiz, MD, InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): May 10, 2016
• Study Completion (Actual): May 10, 2016

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimate): February 18, 2016

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperbilirubinemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Tin mesoporphyrin
• Other Study ID Numbers: 64,185-06LT-2