Stannsoporfin With Light Therapy for Newborn Babies With Jaundice

A Phase 2b Multicenter, Single Dose, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of Two Doses of Stannsoporfin in Combination With Phototherapy in Neonates

Sponsors

Lead Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Source Mallinckrodt
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.

Overall Status Completed
Start Date October 16, 2013
Completion Date March 22, 2016
Primary Completion Date March 22, 2016
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Total Serum Bilirubin (mg/dL) Baseline, 48 hours post-treatment
Secondary Outcome
Measure Time Frame
Time (Hour) at Which TSB First Crosses at or Below the Defined Age-specific Threshold for 54-hours Post-treatment (PT) within 54 hours
Number of Participants With Phototherapy (PT) Failure within 30 days after discharge
Number of Participants With Rebound Hyperbilirubinemia within 54 hours
Enrollment 91
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Phototherapy

Description: Phototherapy starts within 30 minutes before or after injection

Other Name: Light therapy

Intervention Type: Drug

Intervention Name: Stannsoporfin

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

Other Name: Experimental drug

Intervention Type: Drug

Intervention Name: Placebo

Description: Matching placebo administered by IM injection

Arm Group Label: Placebo

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

Gender: All

Minimum Age: N/A

Maximum Age: 72 Hours

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Leader Study Director InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Location
Facility:
Arrowhead Regional Medical Center | Colton, California, 92324, United States
University of California San Diego Medical Center | San Diego, California, 92103, United States
University of CA, San Francisco | San Francisco, California, 94145, United States
Univ Florida Hospital | Jacksonville, Florida, 32209, United States
Kosair Children's Hospital | Louisville, Kentucky, 40202, United States
University of Louisville Hospital | Louisville, Kentucky, 40202, United States
Univ Med Ctr of Southern Nevada | Las Vegas, Nevada, 89102, United States
Rutgers University Hospital | Newark, New Jersey, 07103, United States
Winthrop University Hospital | Mineola, New York, 11501, United States
Stoney Brook Univ Hospital | Stony Brook, New York, 22794, United States
WakeMed Health and Hospitals | Raleigh, North Carolina, 27610, United States
Toledo Children's Hospital | Toledo, Ohio, 43606, United States
Hahnemann University Hospital/St. Christopher's Hospital for Children | Philadelphia, Pennsylvania, 19102, United States
Medical Univ of South Carolina | Charleston, South Carolina, 29425, United States
University of Tennessee Health Science Center | Memphis, Tennessee, 38163, United States
JPS Health Network | Fort Worth, Texas, 76104, United States
Univ Texas Medical Branch | Galveston, Texas, 77555, United States
Children's Hospital of Richmond at VCU | Richmond, Virginia, 23298, United States
Location Countries

United States

Verification Date

February 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Placebo

Type: Placebo Comparator

Description: Participants receive placebo and phototherapy

Label: Stannsoporfin 3.0 mg/kg

Type: Experimental

Description: Participants receive stannsoporfin (3.0 mg/kg) and phototherapy

Label: Stannsoporfin 4.5 mg/kg

Type: Experimental

Description: Participants receive stannsoporfin (4.5 mg/kg) and phototherapy

Acronym JASMINE_204
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Care Provider, Investigator)

Source: ClinicalTrials.gov