Stannsoporfin With Light Therapy for Newborn Babies With Jaundice (NCT01887327) | Clinical Trial Compass
CompletedPhase 2
Stannsoporfin With Light Therapy for Newborn Babies With Jaundice
United States91 participantsStarted 2013-10-16
Plain-language 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.
Who can participate
Age range
1 Hour – 72 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Serum Bilirubin (mg/dL)
Timeframe: Baseline, 48 hours post-treatment
Trial details
NCT IDNCT01887327
SponsorInfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
. 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)