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

October 11, 2019 updated by: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

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

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

No interventions were administered during this follow-up study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

42

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 4 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Babies who participated in protocol 64,185-202 (NCT00850993)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)
Other: Phototherapy (as needed)
No intervention was administered during this observational study
Other Names:
  • Standard Care
Drug: Placebo Control
No intervention was administered during this observational study
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: within 52 months
within 52 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 20, 2008

Primary Completion (ACTUAL)

June 23, 2015

Study Completion (ACTUAL)

November 9, 2015

Study Registration Dates

First Submitted

January 7, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (ESTIMATE)

January 10, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64,185-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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