Follow up Study of Patients Having Participated in Clinical Trial 64,185-204

Study Overview
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Brief Summary
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The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control (placebo plus PT) group in clinical trial 64,185-204.

Detailed Description
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Outcomes will be based on the following variables: Reported AEs and SAEs Hearing assessments Developmental assessments

Official Title
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A Four-Year Blinded Outcomes Follow-up Study of Patients Who Received Stannsoporfin or Placebo in Clinical Trial 64,185-204

Conditions
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Hyperbilirubinemia, Neonatal

Intervention / Treatment
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* Drug: Stannsoporfin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who received IMP (stannsoporfin or placebo) in clinical trial 64,185-204 Parents or guardians have given written informed consent to participate

Ages Eligible for Study
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Minimum Age: 30 Days
Maximum Age: 52 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo<br>Participants received placebo during the earlier study | Drug: Placebo<br>* Matching placebo administered by IM injection<br>* Other names: Matching Placebo;|
| Stannsoporfin 3.0 mg/kg<br>Participants received Stannsoporfin 3.0 mg/kg during the earlier study | Drug: Stannsoporfin<br>* Stannsoporfin administered by intramuscular (IM) injection<br>* Other names: Experimental product;|
| Stannsoporfin 4.5 mg/kg<br>Participants received Stannsoporfin 4.5 mg/kg during the earlier study | Drug: Stannsoporfin<br>* Stannsoporfin administered by intramuscular (IM) injection<br>* Other names: Experimental product;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported adverse events (AEs) |  | 48-52 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing assessments | Conventional audiometry will be performed by a qualified specialist. Any findings from a failed conventional audiology examination will be recorded | 48 - 52 month | 
| Developmental assessments | The Mullen Scales of Early Learning examination has been selected for its standardized measurement of developmental skills in multiple domains (gross motor, visual reception, fine motor, expressive language, and receptive language). Testing will be done at visits 1 and 2 by a healthcare individual trained to administer the test. The Mullen raw scores, T-scores, and age equivalents will be recorded. | 48 - 52 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stannsoporfin