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

Completed
Conditions
Jaundice
Neonatal Hyperbilirubinemia
Interventions
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

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
GroupInterventionDescription
Cohort 1: Stannsoporfin 1.5 mg/kgStannsoporfinCohort 1: Received one 1.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Cohort 4: Placebo ControlPlacebo ControlCohort 4: Received one sterile saline injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Cohort 1: Stannsoporfin 1.5 mg/kgPhototherapy (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/kgPhototherapy (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/kgPhototherapy (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 ControlPhototherapy (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/kgStannsoporfinCohort 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/kgStannsoporfinCohort 2: Received one 3.0 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Primary Outcome Measures
NameTimeMethod
Number of participants with adverse eventswithin 52 months
Secondary Outcome Measures
NameTimeMethod

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