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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017434-45 | EudraCT Number |
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To redefine study population
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannsoporfin | Drug | Stannsoporfin administered as a single IM injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%).](streamdown:incomplete-link) | 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. | Baseline, 48 hrs |
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Inclusion Criteria:
Babies may only participate if they meet all the following criteria:
Exclusion Criteria:
The following criteria will make a baby not eligible to participate:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Team Leader | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrowhead Regional Med Center | Colton | California | 92324 | United States | ||
| UCSD Medical Center |
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Because the cohorts were run sequentially, and the trial was cancelled before they were all enrolled, Cohort 3 enrolled only 8 compared to 15 in Cohort 4.
Fifty-eight (58) babies were enrolled before the trial was prematurely terminated due to cancellation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Stannsoporfin 1.5 mg/kg | 1.5 mg/kg stannsoporfin (with phototherapy as needed) |
| FG001 | Cohort 2: Stannsoporfin 3.0 mg/kg | 3.0 mg/kg stannsoporfin (with phototherapy as needed) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Sequential experimental cohorts are run in parallel with placebo controls.
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Clinical personnel at the site (including investigator, study coordinator and central cardiologist) were blinded to treatment group.
The research pharmacy and the health care provider responsible for giving the injection to patients knew what the treatment was (they were not blinded).
|
| Placebo | Other | Placebo (sterile saline solution) administered as a single IM injection |
|
|
| PhotoTherapy (as needed) | Other | PT standard care administered as needed, based on bilirubin levels throughout the treatment period |
|
|
| San Diego |
| California |
| 92103 |
| United States |
| Kapi'olani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| ECU Brody School of Medicine | Greenville | North Carolina | 27834 | United States |
| St. Vincent Mercy Children's Hospital | Toledo | Ohio | 43608 | United States |
| Drexel University College of Medicine, Clinical Research Group | Philadelphia | Pennsylvania | 19102 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Jan Bizel University Hospital No. 2; Department of Neonatal, Preemies and Neonatal Intensive Care | Bydgoszcz | 85-168 | Poland |
| Research Institute of Polish Mother's Health Center | Lodz | 93-338 | Poland |
| Neonatal Department Warsaw Medical University | Warsaw | 00-315 | Poland |
| Complejo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| Hospital Vall D´Hebrón | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial | Barcelona | E-08036 | Spain |
| Hospital Doce de Octubre | Madrid | 28041 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| University Hospital Santiago de Compostela-L Coruna | Santiago de Compostela | 15706 | Spain |
| 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 | Ukraine |
| National Pediatric Specialized Hospital "OHMATDYT". | Kiev | 1135 | Ukraine |
| State Institution "Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of the Ukraine", Neonatology Department | Kiev | 4050 | Ukraine |
| 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 | Ukraine |
| 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 | Ukraine |
| FG002 | Cohort 3: Stannsoporfin 4.5 mg/kg | 4.5 mg/kg stannsoporfin (with phototherapy as needed) |
| FG003 | Cohort 4: Placebo Control | Placebo control was sterile saline solution (with phototherapy as needed) |
| Safety |
|
| Intent-to-treat |
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| Received Phototherapy |
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| Per Protocol |
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| COMPLETED |
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| NOT COMPLETED |
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|
Intention-to-treat
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Stannsoporfin 1.5 mg/kg | 1.5 mg/kg stannsoporfin (with phototherapy as needed) |
| BG001 | Cohort 2: Stannsoporfin 3.0 mg/kg | 3.0 mg/kg stannsoporfin (with phototherapy as needed) |
| BG002 | Cohort 3: Stannsoporfin 4.5 mg/kg | 4.5 mg/kg stannsoporfin (with phototherapy as needed) |
| BG003 | Cohort 4: Placebo Control | Placebo control was sterile saline solution (with phototherapy as needed) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Gestational Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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%).](streamdown:incomplete-link) | Intent-to-treat population (ITT) | Posted | Median | Full Range | percentage difference from PT threshold | Baseline, 48 hours |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Intention-to-treat | Posted | Median | Full Range | mg/dL | Baseline, 48 hrs |
|
30 days
All adverse events were collected by the investigator except jaundice and hyperbilirubinemia after the first amendment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Stannsoporfin 1.5 mg/kg | 1.5 mg/kg stannsoporfin (with phototherapy as needed) | 0 | 17 | 0 | 17 | 8 | 17 |
| EG001 | Cohort 2: Stannsoporfin 3.0 mg/kg | 3.0 mg/kg stannsoporfin (with phototherapy as needed) | 0 | 18 | 1 | 18 | 10 | 18 |
| EG002 | Cohort 3: Stannsoporfin 4.5 mg/kg | 4.5 mg/kg stannsoporfin (with phototherapy as needed) | 0 | 8 | 1 | 8 | 3 | 8 |
| EG003 | Placebo Control | Sterile saline solution (with phototherapy as needed) | 0 | 15 | 2 | 15 | 5 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| meningitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Jaundice | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA (12.0) | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA (12.0) | Systematic Assessment |
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| Carbon dioxide decreased | Investigations | MedDRA (12.0) | Systematic Assessment |
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| Haemoglobin increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Acne infantile | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Erythema toxicum neonatorum | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Rash neonatal | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
It should be noted that the study was discontinued before enrollment of the full 4.5 mg/kg cohort,and therefore, the stannsoporfin 4.5 mg/kg treatment group included 8 patients and the placebo group included 15 patients.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt Pharmaceuticals | 1-800-844-2830 | 5 | clinicaltrials@mnk.com |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D006461 | Hemolysis |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C055421 | tin mesoporphyrin |
| D012965 | Sodium Chloride |
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D013812 | Therapeutics |
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| 38 Weeks and Above |
|
| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ANCOVA | =0.117 | LS Mean Difference | -10.02 | 2-Sided | 95 | -22.61 | 2.58 | Other |
| ANCOVA | =0.057 | LS Mean Difference | -14.93 | 2-Sided | 95 | -30.31 | 0.44 | Other |
| Units | Counts |
|---|
| Participants |
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|
|