Stannsoporfin With Light Therapy for Newborn Babies With Jaundice

NCT ID: NCT01887327

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-16
• Study Completion Date: 2016-03-22

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 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.

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.

Conditions

Jaundice, Neonatal; Hyperbilirubinemia, Neonatal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Participants receive placebo and phototherapy

Group Type: PLACEBO_COMPARATOR

Phototherapy

Intervention Type: PROCEDURE

Phototherapy starts within 30 minutes before or after injection

Placebo

Intervention Type: DRUG

Matching placebo administered by IM injection

Stannsoporfin 3.0 mg/kg

Participants receive stannsoporfin (3.0 mg/kg) and phototherapy

Group Type: EXPERIMENTAL

Phototherapy

Intervention Type: PROCEDURE

Phototherapy starts within 30 minutes before or after injection

Stannsoporfin

Intervention Type: DRUG

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

Stannsoporfin 4.5 mg/kg

Participants receive stannsoporfin (4.5 mg/kg) and phototherapy

Group Type: EXPERIMENTAL

Phototherapy

Intervention Type: PROCEDURE

Phototherapy starts within 30 minutes before or after injection

Stannsoporfin

Intervention Type: DRUG

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

Interventions

Phototherapy

Phototherapy starts within 30 minutes before or after injection

Intervention Type: PROCEDURE

Stannsoporfin

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

Intervention Type: DRUG

Placebo

Matching placebo administered by IM injection

Intervention Type: DRUG

Other Intervention Names

Light therapy; Experimental drug; Matching placebo; Saline

Eligibility Criteria

Inclusion Criteria

1. 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

2. Parental or guardian consent

3. Birth weight ≥ 2500 grams

4. 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)

5. Parents agree to observe light precautions for 10 days post treatment

Exclusion Criteria

1. Elevated direct bilirubin ≥2 mg/dL, OR > 20% of the total serum bilirubin

2. Alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN) and/or aspartate aminotransferase (AST) > 3 times ULN

3. Abnormal renal function defined as creatinine and/or blood urea nitrogen >2 times the ULN

4. 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

5. Apgar score ≤6 at age 5 minutes

6. An unexplained existing rash or skin erythema

7. Prior exposure to PT

8. Clinical suggestion of neonatal thyroid disease or current uncontrolled thyroid disease in the mother (maternal Hashimoto's disease is not exclusionary)

9. Cardio-respiratory distress, defined as a respiratory rate >60 breaths per minute at time of enrollment

10. Any abnormal auditory or ophthalmologic findings on screening physical exam

11. 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

12. Known porphyrias or risk factors for porphyrias, including family history

13. A maternal history of systemic lupus erythematosus

14. Maternal use of phenobarbital 30 days before, or after delivery, if breast-feeding

15. 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

16. Significant congenital anomalies or infections

17. Risk of requiring surgery or exposure to operating room (OR) lights in the first 2 weeks of life

18. Persistent hypoglycemia (blood glucose <40 mg/dL)

19. Temperature instability defined as temperature consistently (3 consecutive times) <36 degrees centigrade (ºC) and/or >37.5 degrees centigrade (ºC) axillary

20. Use of intravenous immunoglobulin (IVIg) or albumin prior to study drug administration

21. Post-delivery treatment with medications that are known or suspected to displace bilirubin from albumin (e.g., ceftriaxone or sulfa-based antibiotics)

22. Use of photosensitizing drugs or agents

23. Unwillingness of parents/guardians to adhere to recommendations regarding light precautions

24. Exposure to any investigational medications or devices after delivery, or participation in another clinical trial while participating in this trial

25. Any other concurrent medical condition, which in the opinion of the Investigator, makes the patient unsuitable for the clinical trial

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Locations

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

Countries

United States

Other Identifiers

64,185-204

Identifier Type: -

Identifier Source: org_study_id