Nutritional and Metabolic DiseasesPhase 3NCT02685137
Efficacy and Safety of Stannsoporfin in Neonates
A Phase 3 study testing stannsoporfin in people with Nutritional and Metabolic Diseases, run by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company at 1 site in United States.
Trial 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". Read more about this study
- Who is it for?
- Ages 12 to 36 hours
- Conditions the study is for
- Nutritional and Metabolic Diseases
- What is being tested?
- stannsoporfin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2002to Feb 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 to 36 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
About this study
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.
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".
Read the 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.
- Conditions
- Nutritional and Metabolic Diseases
- Being tested
- stannsoporfin, Sham Injection
- Keywords
- Kernicterus, Neonatal Jaundice, Newborn Jaundice, Hyperbilirubinemia, Stannsoporfin
- Medical subject headings
- Nutritional and Metabolic Diseases, Kernicterus, Jaundice, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stannsoporfinDrug
Intramuscular injection of stannsoporfin to treat jaundice.
Sham InjectionOther
nothing
| Study group | Role | What they receive |
|---|---|---|
| Active drug-Stannsoporfin | Experimental | Stannsoporfin, single dose 4.5mg/kg administered Intramuscular (parental injection in the thigh) for treatment of jaundice
20 mg/mL 1.5 mL/vial Receives: Drug: stannsoporfin |
| Reference Therapy-Sham | Sham comparator | Sham Injection, no injection followed by a Band-Aid to thigh Receives: Other: Sham Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for Phototherapy
proportion of cases which need phototherapy in the treated population
Measured: 30 days
Secondary outcomes (1)
hyperbilirubinemia
Change in serum bilirubin values
Measured: 12 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start1 May 2002
- Primary completion16 Mar 2003
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional and Metabolic DiseasesStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 185 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, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685137
- Sponsor's protocol ID
- 64,185-01-3W
- Status last verified
- Jun 2018
- First submitted
- 10 Feb 2016
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02685137
- Acronym / sponsor ID
- 64,185-01-3W
- Conditions
- Nutritional and Metabolic Diseases
- Keywords
- Kernicterus, Neonatal Jaundice, Newborn Jaundice, Hyperbilirubinemia, Stannsoporfin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 May 2002 (actual)
- Primary completion
- 16 Mar 2003 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active drug-Stannsoporfin | Experimental | Drug: stannsoporfinStannsoporfin, single dose 4.5mg/kg administered Intramuscular (parental injection in the thigh) for treatment of jaundice 20 mg/mL 1.5 mL/vial |
| Reference Therapy-Sham | Sham comparator | Other: Sham InjectionSham Injection, no injection followed by a Band-Aid to thigh |
Who may qualify
- Ages
- 12 to 36 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| stannsoporfinIntramuscular injection of stannsoporfin to treat jaundice. | Drug | Active drug-Stannsoporfin |
| Sham Injectionnothing | Other | Reference Therapy-Sham |
Primary outcome
Need for Phototherapy
Time frame: 30 days
proportion of cases which need phototherapy in the treated population
1 secondary outcome
hyperbilirubinemia
Time frame: 12 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
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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
Mallinckrodt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing stannsoporfin in people with Nutritional and Metabolic Diseases, run by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company at 1 site 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 0 inclusion and 4 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 29 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 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Need for Phototherapy (time frame: 30 days). 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 29 Oct 2019.