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

NCT ID: NCT02033096

Last Updated: 2019-10-15

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-20

Study Completion Date

2015-11-09

Brief Summary

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

No interventions were administered during this follow-up study.

Detailed Description

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Conditions

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Jaundice Neonatal Hyperbilirubinemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DRUG

No intervention was administered during this observational study

Phototherapy (as needed)

Intervention Type OTHER

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

Intervention Type DRUG

No intervention was administered during this observational study

Phototherapy (as needed)

Intervention Type OTHER

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

Intervention Type DRUG

No intervention was administered during this observational study

Phototherapy (as needed)

Intervention Type OTHER

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

Intervention Type DRUG

No intervention was administered during this observational study

Phototherapy (as needed)

Intervention Type OTHER

No intervention was administered during this observational study

Interventions

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Stannsoporfin

No intervention was administered during this observational study

Intervention Type DRUG

Placebo Control

No intervention was administered during this observational study

Intervention Type DRUG

Phototherapy (as needed)

No intervention was administered during this observational study

Intervention Type OTHER

Other Intervention Names

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Experimental product Saline Standard Care

Eligibility Criteria

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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
Minimum Eligible Age

30 Days

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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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