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

N/ACompletedNCT02033096

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company42 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Jaundice Neonatal Hyperbilirubinemia

Interventions

StannsoporfinDRUG

No intervention was administered during this observational study

Placebo ControlDRUG

No intervention was administered during this observational study

Phototherapy (as needed)OTHER

No intervention was administered during this observational study

Eligibility

Sex: ALLMin age: 30 DaysMax age: 4 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants with adverse events

Time frame: within 52 months

Data from ClinicalTrials.gov

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