Back to resultsEfficacy and Safety of Stannsoporfin in Neonates
Primary Purpose
Nutritional and Metabolic Diseases
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
stannsoporfin
Sham Injection
Sponsored by
About this trial
This is an interventional prevention trial for Nutritional and Metabolic Diseases focused on measuring Kernicterus, Neonatal Jaundice, Newborn Jaundice, Hyperbilirubinemia, Stannsoporfin
Eligibility Criteria
Patients were enrolled who meet the following criteria:
- The infant's family may be approached at anytime from 6 hours after birth onward to discuss the possibility of enrollment. However, Informed Consent may not be signed until the baby is between 12 and 36 hours of age.
- Consent may be obtained as soon as possible after 12 hours of age, when the baby enters the well-baby nursery.
- An infant may be included if the mother has received, or the baby is receiving, antibiotics and the infant is asymptomatic. For example, the baby has no signs of cardiorespiratory distress and is feeding well. Symptomatic infants are excluded (see Exclusions, below).
- Born at the study hospital site and admitted to the well-baby nursery or admitted to the intensive-care nursery for <12 hours for post delivery observation (delayed transition, temperature or dextrose instability, meconium staining and/or parental concern).
- All babies on oral feeding with stable cardiorespiratory status and deemed "healthy" upon clinical examination, with normal perfusion as defined by capillary filling of the fingernail.
- Term neonate (≥38 weeks of completed gestation), OR
- Near-term neonate (>36<38 weeks of completed gestation; >2,000g birth weight), OR
- Near-term neonate (>35<38 weeks of completed gestation; >2,500g birth weight)
- Care provided (primarily) in the well-baby nursery population;
- Absence of concurrent cardiorespiratory distress, sepsis, major congenital anomalies or need for care in an intensive care nursery;
- Not participating in another concurrent unrelated study.
Exclusion Criteria
The study enrolled patients who did not have any of the following exclusion criteria:
- Any condition that in the opinion of the investigator would make the subject unsuitable for the study.
- Infants receiving antibiotics who are also symptomatic are excluded. For example, a baby who is feeding poorly or is in cardiorespiratory distress is excluded.
- Mother has received phenobarbital in past 30 days.
Sites / Locations
- Pennsylvania Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active drug-Stannsoporfin
Reference Therapy-Sham
Arm Description
Stannsoporfin, single dose 4.5mg/kg administered Intramuscular (parental injection in the thigh) for treatment of jaundice 20 mg/mL 1.5 mL/vial
Sham Injection, no injection followed by a Band-Aid to thigh
Outcomes
Primary Outcome Measures
Need for Phototherapy
proportion of cases which need phototherapy in the treated population
Secondary Outcome Measures
hyperbilirubinemia
Change in serum bilirubin values
Full Information
NCT ID
NCT02685137
First Posted
February 10, 2016
Last Updated
October 25, 2019
Sponsor
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
1. Study Identification
Unique Protocol Identification Number
NCT02685137
Brief Title
Efficacy and Safety of Stannsoporfin in Neonates
Official Title
A Multicenter Study to Evaluate the Efficacy and Safety of Tin Mesoporphyrin (Stannsoporfin) to Reduce the Need for Phototherapy in Term and Near Term Infants.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2002 (Actual)
Primary Completion Date
March 16, 2003 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the well-baby nursery and enrolled with "intention to treat".
Detailed Description
For purposes of analysis, 2 patient populations are defined. One population consists of those babies who did not develop severe hyperbilirubinemia (TSB <9 mg/dL) during the first 36 hours of age. This population is referred to as the untreated population of screened but not randomized patients. The second population of babies was defined as those infants who develop severe hyperbilirubinemia. These infants were randomized to treatment with either stannsoporfin or the sham injection and will be the focus of the efficacy and safety analysis. This population was referred to as the treated population.
The treated population was used for the efficacy and safety analysis. These infants were randomized to either stannsoporfin or the sham injection treatment group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional and Metabolic Diseases
Keywords
Kernicterus, Neonatal Jaundice, Newborn Jaundice, Hyperbilirubinemia, Stannsoporfin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active drug-Stannsoporfin
Arm Type
Experimental
Arm Description
Stannsoporfin, single dose 4.5mg/kg administered Intramuscular (parental injection in the thigh) for treatment of jaundice
20 mg/mL 1.5 mL/vial
Arm Title
Reference Therapy-Sham
Arm Type
Sham Comparator
Arm Description
Sham Injection, no injection followed by a Band-Aid to thigh
Intervention Type
Drug
Intervention Name(s)
stannsoporfin
Intervention Description
Intramuscular injection of stannsoporfin to treat jaundice.
Intervention Type
Other
Intervention Name(s)
Sham Injection
Intervention Description
nothing
Primary Outcome Measure Information:
Title
Need for Phototherapy
Description
proportion of cases which need phototherapy in the treated population
Time Frame
30 days
Secondary Outcome Measure Information:
Title
hyperbilirubinemia
Description
Change in serum bilirubin values
Time Frame
12 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Hours
Maximum Age & Unit of Time
36 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients were enrolled who meet the following criteria:
The infant's family may be approached at anytime from 6 hours after birth onward to discuss the possibility of enrollment. However, Informed Consent may not be signed until the baby is between 12 and 36 hours of age.
Consent may be obtained as soon as possible after 12 hours of age, when the baby enters the well-baby nursery.
An infant may be included if the mother has received, or the baby is receiving, antibiotics and the infant is asymptomatic. For example, the baby has no signs of cardiorespiratory distress and is feeding well. Symptomatic infants are excluded (see Exclusions, below).
Born at the study hospital site and admitted to the well-baby nursery or admitted to the intensive-care nursery for <12 hours for post delivery observation (delayed transition, temperature or dextrose instability, meconium staining and/or parental concern).
All babies on oral feeding with stable cardiorespiratory status and deemed "healthy" upon clinical examination, with normal perfusion as defined by capillary filling of the fingernail.
Term neonate (≥38 weeks of completed gestation), OR
Near-term neonate (>36<38 weeks of completed gestation; >2,000g birth weight), OR
Near-term neonate (>35<38 weeks of completed gestation; >2,500g birth weight)
Care provided (primarily) in the well-baby nursery population;
Absence of concurrent cardiorespiratory distress, sepsis, major congenital anomalies or need for care in an intensive care nursery;
Not participating in another concurrent unrelated study.
Exclusion Criteria
The study enrolled patients who did not have any of the following exclusion criteria:
Any condition that in the opinion of the investigator would make the subject unsuitable for the study.
Infants receiving antibiotics who are also symptomatic are excluded. For example, a baby who is feeding poorly or is in cardiorespiratory distress is excluded.
Mother has received phenobarbital in past 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Stannsoporfin in Neonates
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