Jaundice, Neonatal Clinical Trial
— JASMINE_204Official 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
Verified date | February 2020 |
Source | Mallinckrodt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00735319 -
Transcutaneous Bilirubinometers in the Community
|
N/A | |
Completed |
NCT00114543 -
Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
|
Phase 3 | |
Withdrawn |
NCT04021927 -
Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy
|
N/A | |
Completed |
NCT04632888 -
The Effect of Telephone Support for Breastfeeding Follow-up on Infantile Colic and Maternal Breastfeeding Self-efficacy
|
N/A | |
Not yet recruiting |
NCT04527536 -
Research of Diagnostic Value for BMJ Infants
|
||
Suspended |
NCT03741803 -
Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice
|
N/A | |
Completed |
NCT05650463 -
Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns
|
N/A | |
Terminated |
NCT05623566 -
Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
|
N/A | |
Completed |
NCT02612727 -
Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates
|
N/A | |
Completed |
NCT01434810 -
Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates
|
N/A | |
Completed |
NCT03184948 -
Understanding Neonatal Jaundice in Rwanda
|
N/A | |
Completed |
NCT03942757 -
BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
|
||
Not yet recruiting |
NCT05806684 -
Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
|
||
Completed |
NCT06372093 -
Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana
|
N/A | |
Completed |
NCT03570775 -
Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice
|
N/A | |
Completed |
NCT03569254 -
Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice
|
N/A | |
Completed |
NCT05625880 -
Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population
|
N/A | |
Completed |
NCT01169740 -
Transcutaneous Measurement of Jaundice in the Newborn
|
N/A | |
Not yet recruiting |
NCT06449508 -
The Effectiveness of Probiotics in Neonatal Jaundice
|
Phase 1/Phase 2 | |
Completed |
NCT05623553 -
Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population
|
N/A |