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

Completed

• Conditions: Jaundice; Neonatal Hyperbilirubinemia
• Interventions: Drug: Stannsoporfin; Drug: Placebo Control; Other: Phototherapy (as needed)

• Registration Number: NCT02033096
• Lead Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Brief Summary

Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993).

No interventions were administered during this follow-up study.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-20
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-10
• Primary Completion: 2015-06-23
• Study Completion: 2015-11-09
• Status Verified: 2019-08
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1: Stannsoporfin 1.5 mg/kg	Stannsoporfin	Cohort 1: Received one 1.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Cohort 4: Placebo Control	Placebo Control	Cohort 4: Received one sterile saline injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Cohort 1: Stannsoporfin 1.5 mg/kg	Phototherapy (as needed)	Cohort 1: Received one 1.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Cohort 2: Stannsoporfin 3.0 mg/kg	Phototherapy (as needed)	Cohort 2: Received one 3.0 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Cohort 3: Stannsoporfin 4.5 mg/kg	Phototherapy (as needed)	Cohort 3: Received one 4.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Cohort 4: Placebo Control	Phototherapy (as needed)	Cohort 4: Received one sterile saline injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Cohort 3: Stannsoporfin 4.5 mg/kg	Stannsoporfin	Cohort 3: Received one 4.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Cohort 2: Stannsoporfin 3.0 mg/kg	Stannsoporfin	Cohort 2: Received one 3.0 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	within 52 months