Efficacy and Safety of Stannsoporfin in Neonates

Completed · Phase 3 · Has a placebo group

Conditions studied: Nutritional and Metabolic Diseases

In brief

This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the well-baby nursery and enrolled with "intention to treat".

Key facts

Study ID

NCT02685137

Run by

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

People needed

185

Starts

2002-05-01

Expected to finish

2013-02-01

Last updated by the study team

2019-10-29

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• The study enrolled patients who did not have any of the following exclusion criteria:
• Any condition that in the opinion of the investigator would make the subject unsuitable for the study.
• Infants receiving antibiotics who are also symptomatic are excluded. For example, a baby who is feeding poorly or is in cardiorespiratory distress is excluded.
• Mother has received phenobarbital in past 30 days.

Where it is running

• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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