Stannsoporfin With Light Therapy for Newborn Babies With Jaundice

Jaundice, Neonatal Clinical Trial

— JASMINE_204  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887327
• Other study ID #: 64,185-204
• Status: Completed
• Phase: Phase 2
• Start date: October 16, 2013
• Est. completion date: March 22, 2016

Study information

• Verified date: February 2020
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 22, 2016
• Est. primary completion date: March 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Jaundice
• Jaundice, Neonatal

Intervention

Procedure:
• Phototherapy
Phototherapy starts within 30 minutes before or after injection

Drug:
• Stannsoporfin
Stannsoporfin (3.0 or 4.5 mg/kg) administered by intramuscular (IM) injection (a shot in the muscle)
• Placebo
Matching placebo administered by IM injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Serum Bilirubin (mg/dL)	Total serum bilirubin (TSB) was measured at baseline (the measure that qualified the baby for inclusion) and at 48 hours after treatment. If a baby was discharged before 48 hours, the last measurement before discharge was used [last observation carried forward (LOCF)].	Baseline, 48 hours post-treatment
Secondary	Time (Hour) at Which TSB First Crosses at or Below the Defined Age-specific Threshold for 54-hours Post-treatment (PT)	The hour that 50% of babies in the group (median) first crosses at or below the defined 54-hour threshold for the baby's age	within 54 hours
Secondary	Number of Participants With Phototherapy (PT) Failure	PT failure was defined by any of the following: re-start of PT within 6 hours after stopping; re-hospitalization for hyperbilirubinaemia; use of intravenous immunoglobulin (IVIg); need for an exchange transfusion	within 30 days after discharge
Secondary	Number of Participants With Rebound Hyperbilirubinemia	Rebound hyperbilirubinaemia was defined as an increase in TSB above the age-specific threshold for initiating phototherapy, following the discontinuation of the initial phototherapy.	within 54 hours