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

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ClinicalTrials.gov Identifier: NCT02033096
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt ( InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company )

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
Jaundice Neonatal Hyperbilirubinemia Drug: Stannsoporfin Drug: Placebo Control Other: Phototherapy (as needed)

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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 : October 20, 2008
Actual Primary Completion Date : June 23, 2015
Actual Study Completion Date : November 9, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

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 Name: Experimental product

Other: Phototherapy (as needed)
No intervention was administered during this observational study
Other Name: 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 Name: Experimental product

Other: Phototherapy (as needed)
No intervention was administered during this observational study
Other Name: 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 Name: Experimental product

Other: Phototherapy (as needed)
No intervention was administered during this observational study
Other Name: 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 Name: Saline

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




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: within 52 months ]


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Ages Eligible for Study:   up to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Babies who participated in protocol 64,185-202 (NCT00850993)
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033096


Sponsors and Collaborators
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Investigators
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Study Director: Clinical Study Leader Mallinckrodt

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Responsible Party: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
ClinicalTrials.gov Identifier: NCT02033096     History of Changes
Other Study ID Numbers: 64,185-203
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mallinckrodt ( InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company ):
stannsoporfin
hyperbilirubinemia
heme oxygenase
Additional relevant MeSH terms:
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Hyperbilirubinemia, Neonatal
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Infant, Newborn, Diseases
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action