Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)
NCT ID: NCT02033096
Last Updated: 2019-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2008-10-20
2015-11-09
Brief Summary
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No interventions were administered during this follow-up study.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1: Stannsoporfin 1.5 mg/kg
Cohort 1: Received one 1.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Stannsoporfin
No intervention was administered during this observational study
Phototherapy (as needed)
No intervention was administered during this observational study
Cohort 2: Stannsoporfin 3.0 mg/kg
Cohort 2: Received one 3.0 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Stannsoporfin
No intervention was administered during this observational study
Phototherapy (as needed)
No intervention was administered during this observational study
Cohort 3: Stannsoporfin 4.5 mg/kg
Cohort 3: Received one 4.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Stannsoporfin
No intervention was administered during this observational study
Phototherapy (as needed)
No intervention was administered during this observational study
Cohort 4: Placebo Control
Cohort 4: Received one sterile saline injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
Placebo Control
No intervention was administered during this observational study
Phototherapy (as needed)
No intervention was administered during this observational study
Interventions
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Stannsoporfin
No intervention was administered during this observational study
Placebo Control
No intervention was administered during this observational study
Phototherapy (as needed)
No intervention was administered during this observational study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
30 Days
4 Years
ALL
No
Sponsors
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InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Other Identifiers
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64,185-203
Identifier Type: -
Identifier Source: org_study_id
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