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

Sponsor
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02033096
Collaborator
(none)
42
Enrollment
84.6
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

No interventions were administered during this follow-up study.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
42 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A 4-Year Follow-up, Blinded-Outcomes Trial of Subjects Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202
Actual Study Start Date :
Oct 20, 2008
Actual Primary Completion Date :
Jun 23, 2015
Actual Study Completion Date :
Nov 9, 2015

Arms and Interventions

Arm Intervention/Treatment
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)

Drug: Stannsoporfin
No intervention was administered during this observational study
Other Names:
  • Experimental product

    • Other: Phototherapy (as needed)
    No intervention was administered during this observational study
    Other Names:
  • Standard Care

    		•
    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)

    Drug: Stannsoporfin
    No intervention was administered during this observational study
    Other Names:
  • Experimental product

    • Other: Phototherapy (as needed)
    No intervention was administered during this observational study
    Other Names:
  • Standard Care

    		•
    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)

    Drug: Stannsoporfin
    No intervention was administered during this observational study
    Other Names:
  • Experimental product

    • Other: Phototherapy (as needed)
    No intervention was administered during this observational study
    Other Names:
  • Standard Care

    		•
    Cohort 4: Placebo Control

    Cohort 4: Received one sterile saline injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)

    Drug: Placebo Control
    No intervention was administered during this observational study
    Other Names:
  • Saline

    • Other: Phototherapy (as needed)
    No intervention was administered during this observational study
    Other Names:
  • Standard Care

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with adverse events [within 52 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Days to 4 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

    Investigators

    • Study Director: Clinical Study Leader, Mallinckrodt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
    ClinicalTrials.gov Identifier:
    NCT02033096
    Other Study ID Numbers:
    • 64,185-203
    First Posted:
    Jan 10, 2014
    Last Update Posted:
    Oct 15, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
    stannsoporfin
    hyperbilirubinemia
    heme oxygenase
    Additional relevant MeSH terms:
    Hyperbilirubinemia, Neonatal
    Jaundice
    Hyperbilirubinemia
    Tin mesoporphyrin

    Study Results

    No Results Posted as of Oct 15, 2019