A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

InfaCare Pharmaceuticals Corporation

Status and phase: Terminated; Phase 2

Conditions: Hyperbilirubinemia, Neonatal

Treatments: Drug: Stannsoporfin; Other: PhotoTherapy (as needed); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00850993

2009-017434-45 (EudraCT Number)

64,185-202

Details and patient eligibility

About

It is a normal process in the human body for red blood cells to die, which makes bilirubin.

Bilirubin is cleared away through the liver.

Some babies are born with livers that don't work well enough yet, or their red blood cells are dying too fast, so the baby looks yellow (jaundice).

This means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high.

Phototherapy is what they call the lights they shine on newborn babies to help the liver get rid of bilirubin.

This study tests an experimental drug to see if it can reduce how much bilirubin is being made in the first place.

Full description

The purpose of this study is to determine if an experimental drug, stannsoporfin, is safe and effective in the treatment of hyperbilirubinemia in hemolyzing neonates.

Enrollment: 58 patients

Sex: All

Ages: 1 minute to 48 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

Babies may only participate if they meet all the following criteria:

• Is a term or late preterm baby
• Is at risk for protocol-defined hemolytic disease
• Weighs at least 2500 g (5.5 lbs)
• Has total serum bilirubin (TSB) a specified amount lower than the phototherapy threshold for the age
• Has parents/guardians who are willing to follow light precautions and sign informed consent

Exclusion criteria

The following criteria will make a baby not eligible to participate:

• Needs medications that may prolong the QT interval
• Has family history or risk factors for Long QT Syndrome, Sudden Infant Death Syndrome, or Porphyrias
• Has an Apgar score of 6 or below at age 5 minutes
• Has abnormalities or infections (in mother or child) that per protocol or in the opinion of the investigator may compromise the safety and well-being of the baby or analysis of study results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 4 patient groups, including a placebo group

Cohort 1: Stannsoporfin 1.5 mg/kg

Experimental group

Description:

Participants receive a single dose of 1.5 mg/kg by intramuscular (IM) injection, along with PhotoTherapy (PT) if and when needed.

Treatment:

Other: PhotoTherapy (as needed)

Drug: Stannsoporfin

Cohort 2: Stannsoporfin 3.0 mg/kg

Experimental group

Description:

Participants receive a single dose of 3.0 mg/kg by intramuscular (IM) injection, along with PT if and when needed.

Treatment:

Other: PhotoTherapy (as needed)

Drug: Stannsoporfin

Cohort 3: Stannsoporfin 4.5 mg/kg

Experimental group

Description:

Participants receive a single dose of 4.5 mg/kg by intramuscular (IM) injection, along with PT if and when needed.

Treatment:

Other: PhotoTherapy (as needed)

Drug: Stannsoporfin

Cohort 4: Placebo

Placebo Comparator group

Description:

Participants receive a single dose of placebo (sterile saline solution) by IM injection, along with PT if and when needed.

Treatment:

Other: PhotoTherapy (as needed)

Other: Placebo