Status:
COMPLETED
Stannsoporfin With Light Therapy for Newborn Babies With Jaundice
Lead Sponsor:
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Conditions:
Jaundice, Neonatal
Hyperbilirubinemia, Neonatal
Eligibility:
All Genders
1-72 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Participants randomized (1:1:1) to treatment groups will be term or near-term infants with isoimmune hemolytic disease or glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 16 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2016
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01887327
Start Date
October 16 2013
End Date
March 22 2016
Last Update
February 6 2020
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Arrowhead Regional Medical Center
Colton, California, United States, 92324
2
University of California San Diego Medical Center
San Diego, California, United States, 92103
3
University of CA, San Francisco
San Francisco, California, United States, 94145
4
Univ Florida Hospital
Jacksonville, Florida, United States, 32209