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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.
Outcomes will be based on the following variables:
Reported AEs and SAEs Hearing assessments Developmental assessments
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Participants received placebo during the earlier study |
| |
| Stannsoporfin 3.0 mg/kg | Participants received Stannsoporfin 3.0 mg/kg during the earlier study |
| |
| Stannsoporfin 4.5 mg/kg | Participants received Stannsoporfin 4.5 mg/kg during the earlier study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannsoporfin | Drug | Stannsoporfin administered by intramuscular (IM) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reported adverse events (AEs) | 48-52 month |
| 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 |
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Inclusion Criteria:
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Patients who received a single dose of trial medication in clinical trial 64,185-204.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader, MD | InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company | Study Chair |
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| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C055421 | tin mesoporphyrin |
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| Placebo | Drug | Matching placebo administered by IM injection |
|
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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 |
| D013568 | Pathological Conditions, Signs and Symptoms |