Hyperbilirubinemia, NeonatalPhase 2NCT00850993
A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
A Phase 2 study testing Stannsoporfin and PhotoTherapy (as needed) in people with Hyperbilirubinemia, Neonatal, run by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company at 23 sites in 4 countries.
Trial summary
It is a normal process in the human body for red blood cells to die, which makes bilirubin. Bilirubin is cleared away through the liver. Some babies are born with livers that don't work well enough yet, or their red blood cells are dying too fast, so the baby looks yellow (jaundice). Read more about this study
- Who is it for?
- Ages 1 minute to 48 hours
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- What is being tested?
- Stannsoporfin and PhotoTherapy (as needed)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 23 sitesin 4 countries
- Study dates
- Aug 2008to May 2012
- 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 minute to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Babies may only participate if they meet all the following criteria:
- Is a term or late preterm baby
- Is at risk for protocol-defined hemolytic disease
- Weighs at least 2500 g (5.5 lbs)
- Has total serum bilirubin (TSB) a specified amount lower than the phototherapy threshold for the age
- Has parents/guardians who are willing to follow light precautions and sign informed consent
Who cannot join
- The following criteria will make a baby not eligible to participate:
- Needs medications that may prolong the QT interval
- Has family history or risk factors for Long QT Syndrome, Sudden Infant Death Syndrome, or Porphyrias
- Has an Apgar score of 6 or below at age 5 minutes
- Has abnormalities or infections (in mother or child) that per protocol or in the opinion of the investigator may compromise the safety and well-being of the baby or analysis of study results
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United States9 sites
Arrowhead Regional Med Center
Colton, California, 92324
ECU Brody School of Medicine
Greenville, North Carolina, 27834
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, 96826
University of Louisville
Louisville, Kentucky, 40202
Drexel University College of Medicine, Clinical Research Group
Philadelphia, Pennsylvania, 19102
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
UCSD Medical Center
San Diego, California, 92103
St. Vincent Mercy Children's Hospital
Toledo, Ohio, 43608
Westchester Medical Center
Valhalla, New York, 10595
Spain6 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital Vall D´Hebrón
Barcelona, 08035
Hospital Clinic i Provincial
Barcelona, E-08036
Hospital Doce de Octubre
Madrid, 28041
Hospital La Paz
Madrid, 28046
University Hospital Santiago de Compostela-L Coruna
Santiago de Compostela, 15706
Ukraine5 sites
Municipal Medical Institution "Regional pediatric clinical hospital #1", Department of pathology of the newborns; Bukovynian State Medical University, Department of Pediatrics and Children's Infectious Diseases
Chernivtsi, 58023
National Pediatric Specialized Hospital "OHMATDYT".
Kiev, 1135
State Institution "Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of the Ukraine", Neonatology Department
Kiev, 4050
Municipal Institution "Odessa regional clinical hospital", Department of pathology of the newborns and premature infants; Odessa State Medical University; Chair of Pediatrics #1 and Neonatology
Odesa, 65031
Vinnytsia regional pediatric hospital, Department of pathology of the newborns, Vinnytsia National Medical University named after M.I.Pirogov, Chair of Pediatrics #1
Vinnitsa, 21029
Poland3 sites
Jan Bizel University Hospital No. 2; Department of Neonatal, Preemies and Neonatal Intensive Care
Bydgoszcz, 85-168
Research Institute of Polish Mother's Health Center
Lodz, 93-338
Neonatal Department Warsaw Medical University
Warsaw, 00-315
About this study
Official title: A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
It is a normal process in the human body for red blood cells to die, which makes bilirubin.
Bilirubin is cleared away through the liver.
Some babies are born with livers that don't work well enough yet, or their red blood cells are dying too fast, so the baby looks yellow (jaundice).
This means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high.
Phototherapy is what they call the lights they shine on newborn babies to help the liver get rid of bilirubin.
This study tests an experimental drug to see if it can reduce how much bilirubin is being made in the first place.
Read the detailed description
The purpose of this study is to determine if an experimental drug, stannsoporfin, is safe and effective in the treatment of hyperbilirubinemia in hemolyzing neonates.
- Conditions
- Hyperbilirubinemia, Neonatal
- Being tested
- Stannsoporfin, Placebo, PhotoTherapy (as needed)
- Keywords
- Hemolysis
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StannsoporfinDrug
Also called Experimental product
Stannsoporfin administered as a single IM injection
PlaceboOther
Also called Saline
Placebo (sterile saline solution) administered as a single IM injection
PhotoTherapy (as needed)Other
Also called PT
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Stannsoporfin 1.5 mg/kg | Experimental | Participants receive a single dose of 1.5 mg/kg by intramuscular (IM) injection, along with PhotoTherapy (PT) if and when needed. Receives: Drug: Stannsoporfin; Other: PhotoTherapy (as needed) |
| Cohort 2: Stannsoporfin 3.0 mg/kg | Experimental | Participants receive a single dose of 3.0 mg/kg by intramuscular (IM) injection, along with PT if and when needed. Receives: Drug: Stannsoporfin; Other: PhotoTherapy (as needed) |
| Cohort 3: Stannsoporfin 4.5 mg/kg | Experimental | Participants receive a single dose of 4.5 mg/kg by intramuscular (IM) injection, along with PT if and when needed. Receives: Drug: Stannsoporfin; Other: PhotoTherapy (as needed) |
| Cohort 4: Placebo | Placebo comparator | Participants receive a single dose of placebo (sterile saline solution) by IM injection, along with PT if and when needed. Receives: Other: Placebo; Other: PhotoTherapy (as needed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment.
The adjusted TSB is a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the American Academy of Pediatrics (AAP) Guidelines, ie, an indication of the distance below the PT threshold at the time [(TSB - PT threshold/PT threshold) x 100%).
Measured: Baseline, 48 hours
Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population
Total bilirubin in blood serum was measured at baseline and at 48 hours after the shot. Change from baseline is calculated by subtracting the amount at baseline from the amount at 48 hours. Lower numbers are better.
Measured: Baseline, 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionJun 2011
- Study completionMay 2012
Why it stopped: To redefine study population
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 Hyperbilirubinemia, 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
- Model description
- Sequential experimental cohorts are run in parallel with placebo controls.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Team Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850993
- Sponsor's protocol ID
- 64,185-202
- Other IDs
- 2009-017434-45, 2009
- Status last verified
- Aug 2014
- First submitted
- 24 Feb 2009
- Last updated
- 30 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT00850993
- Acronym / sponsor ID
- 64,185-202
- Conditions
- Hyperbilirubinemia, Neonatal
- Keywords
- Hemolysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: To redefine study population
- Enrolment
- 58 participants (actual)
- Lead sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Posted 29 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a normal process in the human body for red blood cells to die, which makes bilirubin.
Bilirubin is cleared away through the liver.
Some babies are born with livers that don't work well enough yet, or their red blood cells are dying too fast, so the baby looks yellow (jaundice).
This means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high.
Phototherapy is what they call the lights they shine on newborn babies to help the liver get rid of bilirubin.
This study tests an experimental drug to see if it can reduce how much bilirubin is being made in the first place.
Detailed description
The purpose of this study is to determine if an experimental drug, stannsoporfin, is safe and effective in the treatment of hyperbilirubinemia in hemolyzing neonates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Sequential experimental cohorts are run in parallel with placebo controls.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Stannsoporfin 1.5 mg/kg | Experimental | Drug: Stannsoporfin, Other: PhotoTherapy (as needed)Participants receive a single dose of 1.5 mg/kg by intramuscular (IM) injection, along with PhotoTherapy (PT) if and when needed. |
| Cohort 2: Stannsoporfin 3.0 mg/kg | Experimental | Drug: Stannsoporfin, Other: PhotoTherapy (as needed)Participants receive a single dose of 3.0 mg/kg by intramuscular (IM) injection, along with PT if and when needed. |
| Cohort 3: Stannsoporfin 4.5 mg/kg | Experimental | Drug: Stannsoporfin, Other: PhotoTherapy (as needed)Participants receive a single dose of 4.5 mg/kg by intramuscular (IM) injection, along with PT if and when needed. |
| Cohort 4: Placebo | Placebo comparator | Other: Placebo, Other: PhotoTherapy (as needed)Participants receive a single dose of placebo (sterile saline solution) by IM injection, along with PT if and when needed. |
Who may qualify
- Ages
- 1 minute to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Is a term or late preterm baby
- Is at risk for protocol-defined hemolytic disease
- Weighs at least 2500 g (5.5 lbs)
- Has total serum bilirubin (TSB) a specified amount lower than the phototherapy threshold for the age
- Has parents/guardians who are willing to follow light precautions and sign informed consent
Key exclusion criteria (5 listed)
- Needs medications that may prolong the QT interval
- Has family history or risk factors for Long QT Syndrome, Sudden Infant Death Syndrome, or Porphyrias
- Has an Apgar score of 6 or below at age 5 minutes
- Has abnormalities or infections (in mother or child) that per protocol or in the opinion of the investigator may compromise the safety and well-being of the baby or analysis of study results
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 |
|---|---|---|
| StannsoporfinAlso: Experimental productStannsoporfin administered as a single IM injection | Drug | Cohort 1: Stannsoporfin 1.5 mg/kg, Cohort 2: Stannsoporfin 3.0 mg/kg, Cohort 3: Stannsoporfin 4.5 mg/kg |
| PlaceboAlso: SalinePlacebo (sterile saline solution) administered as a single IM injection | Other | Cohort 4: Placebo |
| PhotoTherapy (as needed)Also: PTPT standard care administered as needed, based on bilirubin levels throughout the treatment period | Other | Cohort 1: Stannsoporfin 1.5 mg/kg, Cohort 2: Stannsoporfin 3.0 mg/kg, Cohort 3: Stannsoporfin 4.5 mg/kg, Cohort 4: Placebo |
Primary outcome
Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment.
Time frame: Baseline, 48 hours
The adjusted TSB is a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the American Academy of Pediatrics (AAP) Guidelines, ie, an indication of the distance below the PT threshold at the time [(TSB - PT threshold/PT threshold) x 100%).
Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population
Time frame: Baseline, 48 hrs
Total bilirubin in blood serum was measured at baseline and at 48 hours after the shot. Change from baseline is calculated by subtracting the amount at baseline from the amount at 48 hours. Lower numbers are better.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Clinical Team Leader study director
Mallinckrodt
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stannsoporfin and PhotoTherapy (as needed) in people with Hyperbilirubinemia, Neonatal, run by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company at 23 sites in 4 countries.
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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Spain, Ukraine, Poland. 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 29 Aug 2014). 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?
Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment. (time frame: Baseline, 48 hours). The study lists 2 primary outcomes in all. 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 30 Oct 2019.