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

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

No interventions were administered during this follow-up study.

Completed

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Key information

Conditions

Jaundice Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Neonatal Hyperbilirubinemia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

30 day–4 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stannsoporfin

Drug

No intervention was administered during this observational study

Other names: Experimental product

Placebo Control

Drug

No intervention was administered during this observational study

Other names: Saline

Phototherapy (as needed)

Other

No intervention was administered during this observational study

Other names: Standard Care

Primary outcomes

Number of participants with adverse events

Time frame: within 52 months

Sponsors and collaborators

Lead sponsor

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Industry

Registry information

Official study title

A 4-Year Follow-up, Blinded-Outcomes Trial of Subjects Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202

Important dates

Study start: 2008
Primary completion: 2015
Study completion: 2015
First posted: Jan 10, 2014
Registry last updated: Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed