Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)

Study Overview
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Brief Summary
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Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993). No interventions were administered during this follow-up study.

Official Title
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A 4-Year Follow-up, Blinded-Outcomes Trial of Subjects Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202

Conditions
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Jaundice, Neonatal Hyperbilirubinemia

Intervention / Treatment
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* Drug: Stannsoporfin
* Drug: Placebo Control
* Other: Phototherapy (as needed)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who received treatment in clinical trial 64,185-202 and for whom informed consent was given for long term safety followup Exclusion Criteria: Participants were excluded by the investigator for medical reasons or by parents/guardians withdrawing consent

Ages Eligible for Study
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Minimum Age: 30 Days
Maximum Age: 4 Years

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 |
| --- | --- |
| Cohort 1: Stannsoporfin 1.5 mg/kg<br>Cohort 1: Received one 1.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) | Drug: Stannsoporfin<br>* No intervention was administered during this observational study<br>* Other names: Experimental product;Other: Phototherapy (as needed)<br>* No intervention was administered during this observational study<br>* Other names: Standard Care;|
| Cohort 2: Stannsoporfin 3.0 mg/kg<br>Cohort 2: Received one 3.0 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) | Drug: Stannsoporfin<br>* No intervention was administered during this observational study<br>* Other names: Experimental product;Other: Phototherapy (as needed)<br>* No intervention was administered during this observational study<br>* Other names: Standard Care;|
| Cohort 3: Stannsoporfin 4.5 mg/kg<br>Cohort 3: Received one 4.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) | Drug: Stannsoporfin<br>* No intervention was administered during this observational study<br>* Other names: Experimental product;Other: Phototherapy (as needed)<br>* No intervention was administered during this observational study<br>* Other names: Standard Care;|
| Cohort 4: Placebo Control<br>Cohort 4: Received one sterile saline injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) | Drug: Placebo Control<br>* No intervention was administered during this observational study<br>* Other names: Saline;Other: Phototherapy (as needed)<br>* No intervention was administered during this observational study<br>* Other names: Standard Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | within 52 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stannsoporfin, hyperbilirubinemia, heme oxygenase