Stannsoporfin With Light Therapy for Newborn Babies With Jaundice

Completed · Phase 2 · Has a placebo group

Conditions studied: Jaundice, Neonatal, Hyperbilirubinemia, Neonatal

In brief

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.

Key facts

Study ID

NCT01887327

Run by

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

People needed

91

Starts

2013-10-16

Expected to finish

2016-03-22

Last updated by the study team

2020-02-06

Who can join

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

You may qualify if…

• Term and near term infants ≥35 and ≤ 43 weeks gestational age (GA), age 0-48 hours with antibody (ABO) or rhesus factor (Rh) incompatibility (anti C, c, D, E or e) who are Coombs positive, or age 0-72 hours with G6PD deficiency
• Parental or guardian consent
• Birth weight ≥ 2500 grams
• At or above the age-specific threshold for initiating phototherapy (PT) per the American Academy of Pediatrics (AAP) guidelines based on measurement of total serum bilirubin (TSB)
• Parents agree to observe light precautions for 10 days post treatment

You may not qualify if…

• Elevated direct bilirubin ≥2 mg/dL, OR > 20% of the total serum bilirubin
• Alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN) and/or aspartate aminotransferase (AST) > 3 times ULN
• Abnormal renal function defined as creatinine and/or blood urea nitrogen >2 times the ULN
• Any other clinically significant abnormalities on screening laboratory evaluation [including electrocardiogram (ECG)] that in the opinion of the investigator makes the patient unsuitable for the clinical trial
• Apgar score ≤6 at age 5 minutes
• An unexplained existing rash or skin erythema
• Prior exposure to PT
• Clinical suggestion of neonatal thyroid disease or current uncontrolled thyroid disease in the mother (maternal Hashimoto's disease is not exclusionary)
• Cardio-respiratory distress, defined as a respiratory rate >60 breaths per minute at time of enrollment
• Any abnormal auditory or ophthalmologic findings on screening physical exam
• Treatment or need for treatment in the neonate with medications that are photoreactive or may prolong the QT interval (erythromycin ointment for eye prophylaxis is permitted), or family history of Long QT syndrome
• Known porphyrias or risk factors for porphyrias, including family history
• A maternal history of systemic lupus erythematosus
• Maternal use of phenobarbital 30 days before, or after delivery, if breast-feeding
• Maternal current drug or alcohol abuse, or maternal history of drug or alcohol abuse that, in the opinion of the Investigator, would not make the patient a suitable candidate for participation in the clinical trial
• Significant congenital anomalies or infections
• Risk of requiring surgery or exposure to operating room (OR) lights in the first 2 weeks of life
• Persistent hypoglycemia (blood glucose <40 mg/dL)
• Temperature instability defined as temperature consistently (3 consecutive times) <36 degrees centigrade (ºC) and/or >37.5 degrees centigrade (ºC) axillary
• Use of intravenous immunoglobulin (IVIg) or albumin prior to study drug administration
• Post-delivery treatment with medications that are known or suspected to displace bilirubin from albumin (e.g., ceftriaxone or sulfa-based antibiotics)
• Use of photosensitizing drugs or agents
• Unwillingness of parents/guardians to adhere to recommendations regarding light precautions
• Exposure to any investigational medications or devices after delivery, or participation in another clinical trial while participating in this trial
• Any other concurrent medical condition, which in the opinion of the Investigator, makes the patient unsuitable for the clinical trial

Where it is running

• Arrowhead Regional Medical Center — Colton, California, United States
• University of California San Diego Medical Center — San Diego, California, United States
• University of CA, San Francisco — San Francisco, California, United States
• Univ Florida Hospital — Jacksonville, Florida, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• Univ Med Ctr of Southern Nevada — Las Vegas, Nevada, United States
• Rutgers University Hospital — Newark, New Jersey, United States
• Winthrop University Hospital — Mineola, New York, United States
• Stoney Brook Univ Hospital — Stony Brook, New York, United States
• WakeMed Health and Hospitals — Raleigh, North Carolina, United States
• Toledo Children's Hospital — Toledo, Ohio, United States
• Hahnemann University Hospital/St. Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
• Medical Univ of South Carolina — Charleston, South Carolina, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States
• JPS Health Network — Fort Worth, Texas, United States
• Univ Texas Medical Branch — Galveston, Texas, United States
• Children's Hospital of Richmond at VCU — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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