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Stannsoporfin With Light Therapy for Newborn Babies With Jaundice

NCT01887327 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2020-02-06

Study results available
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Summary

It is normal for red blood cells to die, even in newborn babies. The waste from that is called bilirubin. The liver clears bilirubin out of the body.

Some babies are born with illness that makes red blood cells die too fast, so the liver is not strong enough to keep up with it.

The yellowish color in eyes or skin means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high.

Special lights are put on jaundiced babies (called phototherapy) to help the liver get rid of bilirubin.

This study tests an experimental drug to see if it can help the liver even more, by safely cutting down the amount of bilirubin the body is making in the first place.

Conditions

  • Jaundice, Neonatal
  • Hyperbilirubinemia, Neonatal

Interventions

PROCEDURE

Phototherapy

Phototherapy starts within 30 minutes before or after injection

DRUG

Stannsoporfin

Stannsoporfin (3.0 or 4.5 mg/kg) administered by intramuscular (IM) injection (a shot in the muscle)

DRUG

Placebo

Matching placebo administered by IM injection

Sponsors & Collaborators

  • InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-16
Primary Completion
2016-03-22
Completion
2016-03-22

Countries

  • United States

Study Locations

More Related Trials

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 NCT01887327 on ClinicalTrials.gov