Hyperbilirubinemia, NeonatalJASMINE_205NCT02000830
Follow up Study of Patients Having Participated in Clinical Trial 64,185-204
An observational study of Hyperbilirubinemia, Neonatal, run by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company.
Trial summary
The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control (placebo plus PT) group in clinical trial… Read more about this study
- Who is it for?
- Ages 30 days to 52 months
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- 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
- 68 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2013to 28 Feb 2020
- 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 52 months
- All sexes
- No healthy volunteers
- Child
Study population: Patients who received a single dose of trial medication in clinical trial 64,185-204.
Who may be able to join
- Patients who received IMP (stannsoporfin or placebo) in clinical trial 64,185-204
- Parents or guardians have given written informed consent to participate
Who cannot join
None listed.
About this study
Official title: A Four-Year Blinded Outcomes Follow-up Study of Patients Who Received Stannsoporfin or Placebo in Clinical Trial 64,185-204
The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control (placebo plus PT) group in clinical trial 64,185-204.
Read the detailed description
Outcomes will be based on the following variables:
Reported AEs and SAEs Hearing assessments Developmental assessments
- Conditions
- Hyperbilirubinemia, Neonatal
- Being tested
- Stannsoporfin, Placebo
- Keywords
- stannsoporfin
- Medical subject headings
- Hyperbilirubinemia, Neonatal
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 by intramuscular (IM) injection
PlaceboDrug
Also called Matching Placebo
Matching placebo administered by IM injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Participants received placebo during the earlier study Receives: Drug: Placebo | |
| Stannsoporfin 3.0 mg/kg | Participants received Stannsoporfin 3.0 mg/kg during the earlier study Receives: Drug: Stannsoporfin | |
| Stannsoporfin 4.5 mg/kg | Participants received Stannsoporfin 4.5 mg/kg during the earlier study Receives: Drug: Stannsoporfin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported adverse events (AEs)
Measured: 48-52 month
Secondary outcomes (2)
Hearing assessments
Conventional audiometry will be performed by a qualified specialist. Any findings from a failed conventional audiology examination will be recorded
Measured: 48 - 52 month
Developmental assessments
The Mullen Scales of Early Learning examination has been selected for its standardized measurement of developmental skills in multiple domains (gross motor, visual reception, fine motor, expressive language, and receptive language). Testing will be done at visits 1 and 2 by a healthcare individual trained to administer the test. The Mullen raw scores, T-scores, and age equivalents will be recorded.
Measured: 48 - 52 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study start17 Oct 2013
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 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, MD, Study chair, InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000830
- Sponsor's protocol ID
- 64,185-205
- Acronym
- JASMINE_205
- Status last verified
- Jan 2021
- First submitted
- 28 Jun 2013
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four-Year Blinded Outcomes Follow-up Study of Patients Who Received Stannsoporfin or Placebo in Clinical Trial 64,185-204
- ClinicalTrials.gov ID
- NCT02000830
- Acronym / sponsor ID
- JASMINE_205 / 64,185-205
- Conditions
- Hyperbilirubinemia, Neonatal
- Keywords
- stannsoporfin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2013 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 4 Dec 2013 (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.
The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control (placebo plus PT) group in clinical trial 64,185-204.
Detailed description
Outcomes will be based on the following variables:
Reported AEs and SAEs Hearing assessments Developmental assessments
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | – | Drug: PlaceboParticipants received placebo during the earlier study |
| Stannsoporfin 3.0 mg/kg | – | Drug: StannsoporfinParticipants received Stannsoporfin 3.0 mg/kg during the earlier study |
| Stannsoporfin 4.5 mg/kg | – | Drug: StannsoporfinParticipants received Stannsoporfin 4.5 mg/kg during the earlier study |
Who may qualify
- Ages
- 30 days to 52 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients who received a single dose of trial medication in clinical trial 64,185-204.
Key inclusion criteria (2 listed)
- Patients who received IMP (stannsoporfin or placebo) in clinical trial 64,185-204
- Parents or guardians have given written informed consent to participate
Key exclusion criteria (0 listed)
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 by intramuscular (IM) injection | Drug | Stannsoporfin 3.0 mg/kg, Stannsoporfin 4.5 mg/kg |
| PlaceboAlso: Matching PlaceboMatching placebo administered by IM injection | Drug | Placebo |
Primary outcome
Reported adverse events (AEs)
Time frame: 48-52 month
2 secondary outcomes
Hearing assessments
Time frame: 48 - 52 month
Developmental assessments
Time frame: 48 - 52 month
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 2 Feb 2021.
- 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.
Global Clinical Leader, MD study chair
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperbilirubinemia, Neonatal, 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 2 inclusion and 0 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 2 Feb 2021. 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?
Reported adverse events (AEs) (time frame: 48-52 month). 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 2 Feb 2021.