JaundiceNCT02033096
Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)
An observational study of Jaundice and Neonatal Hyperbilirubinemia, run by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company.
Trial summary
Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993). No interventions were administered during this follow-up study. Read more about this study
- Who is it for?
- Ages 30 days to 4 years
- Conditions the study is for
- Jaundice, Neonatal Hyperbilirubinemia
- 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
- 42 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2008to 9 Nov 2015
- Phase
- Observational
- 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 30 days to 4 years
- All sexes
- No healthy volunteers
- Child
Study population: Babies who participated in protocol 64,185-202 (NCT00850993)
Who may be able to join
- Participants who received treatment in clinical trial 64,185-202 and for whom informed consent was given for long term safety followup
Who cannot join
- Participants were excluded by the investigator for medical reasons or by parents/guardians withdrawing consent
About this study
Official title: A 4-Year Follow-up, Blinded-Outcomes Trial of Subjects Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202
Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993).
No interventions were administered during this follow-up study.
- Conditions
- Jaundice, Neonatal Hyperbilirubinemia
- Being tested
- Stannsoporfin, Placebo Control, Phototherapy (as needed)
- Keywords
- stannsoporfin, hyperbilirubinemia, heme oxygenase
- Medical subject headings
- Jaundice, Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StannsoporfinDrug
Also called Experimental product
No intervention was administered during this observational study
Placebo ControlDrug
Also called Saline
No intervention was administered during this observational study
Phototherapy (as needed)Other
Also called Standard Care
No intervention was administered during this observational study
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Stannsoporfin 1.5 mg/kg | Cohort 1: Received one 1.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) Receives: Drug: Stannsoporfin; Other: Phototherapy (as needed) | |
| Cohort 2: Stannsoporfin 3.0 mg/kg | Cohort 2: Received one 3.0 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) Receives: Drug: Stannsoporfin; Other: Phototherapy (as needed) | |
| Cohort 3: Stannsoporfin 4.5 mg/kg | Cohort 3: Received one 4.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) Receives: Drug: Stannsoporfin; Other: Phototherapy (as needed) | |
| Cohort 4: Placebo Control | Cohort 4: Received one sterile saline injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) Receives: Drug: Placebo Control; Other: Phototherapy (as needed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: within 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study start20 Oct 2008
- Primary completion23 Jun 2015
- Study completion9 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for JaundiceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033096
- Sponsor's protocol ID
- 64,185-203
- Status last verified
- Aug 2019
- First submitted
- 7 Jan 2014
- Last updated
- 15 Oct 2019
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Year Follow-up, Blinded-Outcomes Trial of Subjects Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202
- ClinicalTrials.gov ID
- NCT02033096
- Acronym / sponsor ID
- 64,185-203
- Conditions
- Jaundice, Neonatal Hyperbilirubinemia
- Keywords
- stannsoporfin, hyperbilirubinemia, heme oxygenase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2008 (actual)
- Primary completion
- 23 Jun 2015 (actual)
- Study completion
- 9 Nov 2015 (actual)
- First posted
- 10 Jan 2014 (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.
Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993).
No interventions were administered during this follow-up study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Stannsoporfin 1.5 mg/kg | – | Drug: Stannsoporfin, Other: Phototherapy (as needed)Cohort 1: Received one 1.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) |
| Cohort 2: Stannsoporfin 3.0 mg/kg | – | Drug: Stannsoporfin, Other: Phototherapy (as needed)Cohort 2: Received one 3.0 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) |
| Cohort 3: Stannsoporfin 4.5 mg/kg | – | Drug: Stannsoporfin, Other: Phototherapy (as needed)Cohort 3: Received one 4.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) |
| Cohort 4: Placebo Control | – | Drug: Placebo Control, Other: Phototherapy (as needed)Cohort 4: Received one sterile saline injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) |
Who may qualify
- Ages
- 30 days to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Babies who participated in protocol 64,185-202 (NCT00850993)
Key inclusion criteria (1 listed)
- Participants who received treatment in clinical trial 64,185-202 and for whom informed consent was given for long term safety followup
Key exclusion criteria (1 listed)
- Participants were excluded by the investigator for medical reasons or by parents/guardians withdrawing consent
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 productNo intervention was administered during this observational study | Drug | Cohort 1: Stannsoporfin 1.5 mg/kg, Cohort 2: Stannsoporfin 3.0 mg/kg, Cohort 3: Stannsoporfin 4.5 mg/kg |
| Placebo ControlAlso: SalineNo intervention was administered during this observational study | Drug | Cohort 4: Placebo Control |
| Phototherapy (as needed)Also: Standard CareNo intervention was administered during this observational study | 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 Control |
Primary outcome
Number of participants with adverse events
Time frame: within 52 months
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 15 Oct 2019.
- 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 Study Leader study director
Mallinckrodt
Questions about this trial
What is this clinical trial studying?
An observational study of Jaundice and Neonatal Hyperbilirubinemia, run by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company.
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 1 inclusion and 1 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 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Number of participants with adverse events (time frame: within 52 months). 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 15 Oct 2019.