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NCT02033096 Clinical Trial

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

Neonatal Hyperbilirubinemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02033096
Other study ID # 64,185-203
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 20, 2008
Est. completion date November 9, 2015

Study information
Verified date August 2019
Source Mallinckrodt
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

No interventions were administered during this follow-up study.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date November 9, 2015
Est. primary completion date June 23, 2015
Accepts healthy volunteers No
Gender All
Age group N/A to 4 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Stannsoporfin
No intervention was administered during this observational study
• Placebo Control
No intervention was administered during this observational study
Other:
• Phototherapy (as needed)
No intervention was administered during this observational study

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events within 52 months
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