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Follow up Study of Patients Having Participated in Clinical Trial 64,185-204 — JASMINE_205  

Hyperbilirubinemia, Neonatal Clinical Trial

Official title:
A Four-Year Blinded Outcomes Follow-up Study of Patients Who Received Stannsoporfin or Placebo in Clinical Trial 64,185-204

Clinical Trial 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.

Clinical Trial Description

Outcomes will be based on the following variables: Reported AEs and SAEs Hearing assessments Developmental assessments ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02000830
Study type Observational
Source Mallinckrodt
Contact
Status Completed
Phase
Start date October 17, 2013
Completion date February 28, 2020
View Details
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