Follow up Study of Patients Having Participated in Clinical Trial 64,185-204

NCT ID: NCT02000830

Last Updated: 2021-02-02

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

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-17

Study Completion Date

2020-02-28

Brief Summary

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The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control (placebo plus PT) group in clinical trial 64,185-204.

Detailed Description

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Outcomes will be based on the following variables:

Reported AEs and SAEs Hearing assessments Developmental assessments

Conditions

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Hyperbilirubinemia, Neonatal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Placebo

Participants received placebo during the earlier study

Placebo

Intervention Type DRUG

Matching placebo administered by IM injection

Stannsoporfin 3.0 mg/kg

Participants received Stannsoporfin 3.0 mg/kg during the earlier study

Stannsoporfin

Intervention Type DRUG

Stannsoporfin administered by intramuscular (IM) injection

Stannsoporfin 4.5 mg/kg

Participants received Stannsoporfin 4.5 mg/kg during the earlier study

Stannsoporfin

Intervention Type DRUG

Stannsoporfin administered by intramuscular (IM) injection

Interventions

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Stannsoporfin

Stannsoporfin administered by intramuscular (IM) injection

Intervention Type DRUG

Placebo

Matching placebo administered by IM injection

Intervention Type DRUG

Other Intervention Names

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Experimental product Matching Placebo

Eligibility Criteria

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Inclusion Criteria

* Patients who received IMP (stannsoporfin or placebo) in clinical trial 64,185-204
* Parents or guardians have given written informed consent to participate
Minimum Eligible Age

30 Days

Maximum Eligible Age

52 Months

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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Global Clinical Leader, MD

Role: STUDY_CHAIR

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Other Identifiers

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64,185-205

Identifier Type: -

Identifier Source: org_study_id

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