CompletedNCT01887327JASMINE_204Updated Feb 6, 2020Results posted

Stannsoporfin With Light Therapy for Newborn Babies With Jaundice

A Phase 2 interventional study of Phototherapy and Stannsoporfin in Jaundice, Neonatal and Hyperbilirubinemia, Neonatal, sponsored by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company. Completed at 18 sites in United States. Open to participants aged 1 Hour to 72 Hours. Per ClinicalTrials.gov, last updated 2020-02-06.

Sponsored by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 91
Allocation: Randomized
Ages: 1 Hour to 72 Hours
Sex: All

Study 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.

Read the 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 studied

Jaundice, Neonatal
Hyperbilirubinemia, Neonatal

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Keywords

G6PD deficiency
Antibody (ABO) incompatibility
Coombs positive ABO/ rhesus factor (RH) incompatibility
Intensive phototherapy in neonates

In context

Hyperbilirubinemia, Neonatal

93 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.

This study's enrollment of 91 is close to the median of 94 across 59 interventional studies indexed under Hyperbilirubinemia, Neonatal.

Browse Hyperbilirubinemia, Neonatal studies →

Lead sponsor

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Hour to 72 Hours
Sexes eligible: All
Accepts healthy volunteers: No

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

Exclusion Criteria:

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)
Cardio-respiratory distress, defined as a respiratory rate >60 breaths per minute at time of enrollment
Any abnormal auditory or ophthalmologic findings on screening physical exam
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
Known porphyrias or risk factors for porphyrias, including family history
A maternal history of systemic lupus erythematosus
Maternal use of phenobarbital 30 days before, or after delivery, if breast-feeding
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
Significant congenital anomalies or infections
Risk of requiring surgery or exposure to operating room (OR) lights in the first 2 weeks of life
Persistent hypoglycemia (blood glucose \<40 mg/dL)
Temperature instability defined as temperature consistently (3 consecutive times) \<36 degrees centigrade (ºC) and/or >37.5 degrees centigrade (ºC) axillary
Use of intravenous immunoglobulin (IVIg) or albumin prior to study drug administration
Post-delivery treatment with medications that are known or suspected to displace bilirubin from albumin (e.g., ceftriaxone or sulfa-based antibiotics)
Use of photosensitizing drugs or agents
Unwillingness of parents/guardians to adhere to recommendations regarding light precautions
Exposure to any investigational medications or devices after delivery, or participation in another clinical trial while participating in this trial
Any other concurrent medical condition, which in the opinion of the Investigator, makes the patient unsuitable for the clinical trial

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Care provider, Investigator)
Enrollment: 91 participants (actual)

Study arms

Placebo comparator
Placebo
Participants receive placebo and phototherapy
Procedure: Phototherapy · Drug: Placebo
Experimental
Stannsoporfin 3.0 mg/kg
Participants receive stannsoporfin (3.0 mg/kg) and phototherapy
Procedure: Phototherapy · Drug: Stannsoporfin
Experimental
Stannsoporfin 4.5 mg/kg
Participants receive stannsoporfin (4.5 mg/kg) and phototherapy
Procedure: Phototherapy · Drug: Stannsoporfin

Interventions

ProcedurePhototherapy
Phototherapy starts within 30 minutes before or after injection
Also known as: Light therapy
DrugStannsoporfin
Stannsoporfin (3.0 or 4.5 mg/kg) administered by intramuscular (IM) injection (a shot in the muscle)
Also known as: Experimental drug
DrugPlacebo
Matching placebo administered by IM injection
Also known as: Matching placebo, Saline

What researchers measure

Primary outcomes

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 \[last observation carried forward (LOCF)\].
Time frame: Baseline, 48 hours post-treatment

Secondary outcomes

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
Time frame: within 54 hours
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
Time frame: within 30 days after discharge
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.
Time frame: within 54 hours

Results

Posted Nov 13, 2019

Participant flow

Participant flow — Overall Study
Milestone	3.0 mg/kg Stannsoporfin	4.5 mg/kg Stannsoporfin	Placebo
Started	30	31	30
Completed	29	27	27
Not completed	1	4	3

Outcome measures

PrimaryTotal 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 \[last observation carried forward (LOCF)\].

Time frame:: Baseline, 48 hours post-treatment
Reported as:: Mean · mg/dL

Total Serum Bilirubin (mg/dL)
mg/dL	3.0 mg/kg Stannsoporfin	4.5 mg/kg Stannsoporfin	Placebo
Baseline	9.82 ± 2.641	9.97 ± 2.967	9.92 ± 2.211
48 hours post-treatment	8.48 ± 1.973	8.86 ± 2.142	11.67 ± 2.337

Statistical analysis

3.0 mg/kg Stannsoporfin vs Placebo · LS Mean Difference vs Placebo · p = =0.0000021 · Ls mean difference vs placebo: -31.64 · 95% CI -44.000 to -19.283
4.5 mg/kg Stannsoporfin vs Placebo · LS Mean Difference vs Placebo · p = =0.0000260 · Ls mean difference vs placebo: -27.40 · 95% CI -39.657 to -15.142

SecondaryTime (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

Time frame:: within 54 hours
Reported as:: Median · hours

Time (Hour) at Which TSB First Crosses at or Below the Defined Age-specific Threshold for 54-hours Post-treatment (PT)
hours	3.0 mg/kg Stannsoporfin	4.5 mg/kg Stannsoporfin	Placebo
Time (Hour) at Which TSB First Crosses at or Below the Defined Age-specific Threshold for 54-hours Post-treatment (PT)	11.8 (-3.7 to 53.6)	10.6 (-5.5 to 28.5)	20.9 (-4.4 to 54.0)

SecondaryNumber 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

Time frame:: within 30 days after discharge
Reported as:: Count of participants · Participants

Number of Participants With Phototherapy (PT) Failure
Participants	3.0 mg/kg Stannsoporfin	4.5 mg/kg Stannsoporfin	Placebo
PT failure Occurred	3	1	8
Did not occur	27	30	22

SecondaryNumber 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.

Time frame:: within 54 hours
Reported as:: Count of participants · Participants

Number of Participants With Rebound Hyperbilirubinemia
Participants	3.0 mg/kg Stannsoporfin	4.5 mg/kg Stannsoporfin	Placebo
Occurred	0	1	3
Did not occur	30	30	27

Adverse events

Collected over within 30 Days. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
3.0 mg/kg Stannsoporfin	0/30 (0%)	5/30 (16.7%)	28/30 (93.3%)
4.5mg/kg Stannsoporfin	0/31 (0%)	4/31 (12.9%)	21/31 (67.7%)
Placebo	0/30 (0%)	6/30 (20%)	22/30 (73.3%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	3.0 mg/kg Stannsoporfin	4.5mg/kg Stannsoporfin	Placebo
HyperbilirubinaemiaHepatobiliary disorders	1/30	1/31	3/30
Medical observationInvestigations	2/30	0/31	0/30
LeukocytosisBlood and lymphatic system disorders	1/30	0/31	0/30
Supraventricular tachycardiaCardiac disorders	1/30	0/31	0/30
ABO incompatibilityImmune system disorders	0/30	0/31	1/30
Hematocrit decreasedInvestigations	0/30	0/31	1/30
Haemoglobin decreasedInvestigations	0/30	0/31	1/30
Reticulocyte count increasedInvestigations	0/30	0/31	1/30
TachypnoeaRespiratory, thoracic and mediastinal disorders	1/30	0/31	0/30
Bacterial sepsisInfections and infestations	0/30	1/31	0/30

Most frequent other events

Showing 10 of 97

Most frequent other events
Event	3.0 mg/kg Stannsoporfin	4.5mg/kg Stannsoporfin	Placebo
Cardiac murmurInvestigations	5/30	4/31	4/30
ErythemaSkin and subcutaneous tissue disorders	5/30	5/31	0/30
Umbilical herniaGastrointestinal disorders	4/30	1/31	0/30
HyperbilirubinaemiaHepatobiliary disorders	2/30	1/31	3/30
Dry skinSkin and subcutaneous tissue disorders	2/30	3/31	3/30
Erythema toxicum neonatorumSkin and subcutaneous tissue disorders	1/30	2/31	3/30
RashSkin and subcutaneous tissue disorders	3/30	1/31	3/30
Seborrhoeic dermatitisSkin and subcutaneous tissue disorders	3/30	1/31	0/30
Reticulocyte count increasedInvestigations	2/30	3/31	1/30
AnaemiaBlood and lymphatic system disorders	1/30	0/31	2/30

Baseline characteristics

ITT Analysis Set

Age, Continuous
Age, Continuous(Hour)	3.0 mg/kg Stannsoporfin	4.5 mg/kg Stannsoporfin	Placebo	Total
Mean	21.66 ± 11.417	24.05 ± 11.020	25.92 ± 12.361	23.88 ± 11.608

Sex: Female, Male
Sex: Female, Male(Participants)	3.0 mg/kg Stannsoporfin	4.5 mg/kg Stannsoporfin	Placebo	Total
Female	15	15	13	43
Male	15	16	17	48

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	3.0 mg/kg Stannsoporfin	4.5 mg/kg Stannsoporfin	Placebo	Total
Hispanic or Latino	7	9	15	31
Not Hispanic or Latino	23	22	15	60
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	3.0 mg/kg Stannsoporfin	4.5 mg/kg Stannsoporfin	Placebo	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	16	13	9	38
White	9	13	12	34
More than one race	4	5	8	17
Unknown or Not Reported	1	0	0	1

Age at Qualifying TSB
Age at Qualifying TSB(Participants)	3.0 mg/kg Stannsoporfin	4.5 mg/kg Stannsoporfin	Placebo	Total
Less than or equal to 12 h	13	12	10	35
Greater than 12 h to Less than or equal to 24 h	11	8	7	26
Greater than 24 h to Less than or equal to 32 h	3	7	7	17
Greater than 32 h to Less than or equal to 40 h	1	2	3	6
Greater than 40 h	2	2	3	7

Study locations

18 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01887327
Lead sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Responsible party: Sponsor
First posted: Jun 26, 2013
Start date: Oct 16, 2013
Primary completion: Mar 22, 2016
Completion: Mar 22, 2016
Results posted: Nov 13, 2019
Last update: Feb 6, 2020

Study contacts

Global Clinical Leader

study director · InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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