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

NCT02000830 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2021-02-02

No results posted yet for this study

Summary

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.

Conditions

  • Hyperbilirubinemia, Neonatal

Interventions

DRUG

Stannsoporfin

Stannsoporfin administered by intramuscular (IM) injection

DRUG

Placebo

Matching placebo administered by IM injection

Sponsors & Collaborators

  • InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader, MD · InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Eligibility

Min Age
30 Days
Max Age
52 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-17
Primary Completion
2020-02-28
Completion
2020-02-28

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02000830 on ClinicalTrials.gov