Jaundice, NeonatalPhase 2JASMINE_204NCT01887327
Stannsoporfin With Light Therapy for Newborn Babies With Jaundice
A Phase 2 study testing Phototherapy and Stannsoporfin in people with Jaundice, Neonatal and Hyperbilirubinemia, Neonatal, run by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 1 hour to 72 hours
- Conditions the study is for
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
- What is being tested?
- Phototherapy and Stannsoporfin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 18 sitesUnited States
- Study dates
- 16 Oct 2013to 22 Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Medical Univ of South Carolina
Charleston, South Carolina, 29425
Arrowhead Regional Medical Center
Colton, California, 92324
JPS Health Network
Fort Worth, Texas, 76104
Univ Texas Medical Branch
Galveston, Texas, 77555
Univ Florida Hospital
Jacksonville, Florida, 32209
Univ Med Ctr of Southern Nevada
Las Vegas, Nevada, 89102
Kosair Children's Hospital
Louisville, Kentucky, 40202
University of Louisville Hospital
Louisville, Kentucky, 40202
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Winthrop University Hospital
Mineola, New York, 11501
Rutgers University Hospital
Newark, New Jersey, 07103
Hahnemann University Hospital/St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19102
WakeMed Health and Hospitals
Raleigh, North Carolina, 27610
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23298
University of California San Diego Medical Center
San Diego, California, 92103
University of CA, San Francisco
San Francisco, California, 94145
Stoney Brook Univ Hospital
Stony Brook, New York, 22794
Toledo Children's Hospital
Toledo, Ohio, 43606
About this study
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
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
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
- Being tested
- Phototherapy, Stannsoporfin, Placebo
- Keywords
- G6PD deficiency, Antibody (ABO) incompatibility, Coombs positive ABO/ rhesus factor (RH) incompatibility, Intensive phototherapy in neonates
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal, Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyProcedure or surgery
Also called Light therapy
Phototherapy starts within 30 minutes before or after injection
StannsoporfinDrug
Also called Experimental drug
Stannsoporfin (3.0 or 4.5 mg/kg) administered by intramuscular (IM) injection (a shot in the muscle)
PlaceboDrug
Also called Matching placebo, Saline
Matching placebo administered by IM injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants receive placebo and phototherapy Receives: Procedure: Phototherapy; Drug: Placebo |
| Stannsoporfin 3.0 mg/kg | Experimental | Participants receive stannsoporfin (3.0 mg/kg) and phototherapy Receives: Procedure: Phototherapy; Drug: Stannsoporfin |
| Stannsoporfin 4.5 mg/kg | Experimental | Participants receive stannsoporfin (4.5 mg/kg) and phototherapy Receives: Procedure: Phototherapy; Drug: Stannsoporfin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)].
Measured: Baseline, 48 hours post-treatment
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: within 54 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study start16 Oct 2013
- Primary completion22 Mar 2016
- Study completion22 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Jaundice, NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887327
- Sponsor's protocol ID
- 64,185-204
- Acronym
- JASMINE_204
- Status last verified
- Feb 2020
- First submitted
- 24 Jun 2013
- Last updated
- 6 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01887327
- Acronym / sponsor ID
- JASMINE_204 / 64,185-204
- Conditions
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
- Keywords
- G6PD deficiency, Antibody (ABO) incompatibility, Coombs positive ABO/ rhesus factor (RH) incompatibility, Intensive phototherapy in neonates
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2013 (actual)
- Primary completion
- 22 Mar 2016 (actual)
- Study completion
- 22 Mar 2016 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Posted 13 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Procedure: Phototherapy, Drug: PlaceboParticipants receive placebo and phototherapy |
| Stannsoporfin 3.0 mg/kg | Experimental | Procedure: Phototherapy, Drug: StannsoporfinParticipants receive stannsoporfin (3.0 mg/kg) and phototherapy |
| Stannsoporfin 4.5 mg/kg | Experimental | Procedure: Phototherapy, Drug: StannsoporfinParticipants receive stannsoporfin (4.5 mg/kg) and phototherapy |
Who may qualify
- Ages
- 1 hour to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhototherapyAlso: Light therapyPhototherapy starts within 30 minutes before or after injection | Procedure or surgery | Placebo, Stannsoporfin 3.0 mg/kg, Stannsoporfin 4.5 mg/kg |
| StannsoporfinAlso: Experimental drugStannsoporfin (3.0 or 4.5 mg/kg) administered by intramuscular (IM) injection (a shot in the muscle) | Drug | Stannsoporfin 3.0 mg/kg, Stannsoporfin 4.5 mg/kg |
| PlaceboAlso: Matching placebo, SalineMatching placebo administered by IM injection | Drug | Placebo |
Primary outcome
Total Serum Bilirubin (mg/dL)
Time frame: Baseline, 48 hours post-treatment
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)].
3 secondary outcomes
Time (Hour) at Which TSB First Crosses at or Below the Defined Age-specific Threshold for 54-hours Post-treatment (PT)
Time frame: within 54 hours
Number of Participants With Phototherapy (PT) Failure
Time frame: within 30 days after discharge
Number of Participants With Rebound Hyperbilirubinemia
Time frame: within 54 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phototherapy and Stannsoporfin in people with Jaundice, Neonatal and Hyperbilirubinemia, Neonatal, run by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Serum Bilirubin (mg/dL) (time frame: Baseline, 48 hours post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.