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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02033096
Enrollment
42
Registered
2014-01-10
Start date
2008-10-20
Completion date
2015-11-09
Last updated
2019-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaundice, Neonatal Hyperbilirubinemia

Keywords

stannsoporfin, hyperbilirubinemia, heme oxygenase

Brief summary

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

Interventions

DRUGStannsoporfin

No intervention was administered during this observational study

DRUGPlacebo Control

No intervention was administered during this observational study

OTHERPhototherapy (as needed)

No intervention was administered during this observational study

Sponsors

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Days to 4 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of participants with adverse eventswithin 52 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026