HyperbilirubinemiaNCT02685189
Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)
An observational study of Hyperbilirubinemia, run by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company.
Trial summary
The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion". Read more about this study
- Who is it for?
- Ages 1 day to 60 days
- Conditions the study is for
- Hyperbilirubinemia
- What is being tested?
- Previous exposure to stannsoporfin
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to 10 May 2016
- 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 1 day to 60 days
- All sexes
- No healthy volunteers
- Child
Study population: All children who have been enrolled and received Stanate® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up.
Who may be able to join
- All children who have been enrolled and received Stanate® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up.
Who cannot join
- -
About this study
Official title: Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)(WS)(ISNHP)
The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion".
Read the detailed description
The purpose of this protocol is to provide a mechanism to collect Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion". Data on long-term impact of Stannsoporfin on the physical, neurological, neurodevelopmental, biochemical, metabolic and hematopoietic profiles of the children will be collected at 9 and 18 months, 3, 6 and 9 years after Stannsoporfin administration
- Conditions
- Hyperbilirubinemia
- Being tested
- Previous exposure to stannsoporfin
- Medical subject headings
- Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Previous exposure to stannsoporfinOther
No intervention in this protocol
| Study group | Role | What they receive |
|---|---|---|
| 0.75 mg/kg Previous exposure to stannsoporfin | Previous exposure 0.75 mg/kg Receives: Other: Previous exposure to stannsoporfin | |
| 1.5 mg/kg Previous exposure to stannsoporfin | Previous exposure 1.5 mg/kg Receives: Other: Previous exposure to stannsoporfin |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEUROLOGICAL EXAMINATION; Child Behavior Check List
Child Behavior Check List is a standardized measure in child psychology for evaluating maladaptive behavioral and emotional problems in preschool patients
Measured: 10 years
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 startJul 2006
- Primary completion10 May 2016
- Study completion10 May 2016
Why it stopped: Study stopped for business reasons and not for any safety reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperbilirubinemiaStudies 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Ruiz, MD, Study director, InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685189
- Sponsor's protocol ID
- 64,185-06LT-2
- Status last verified
- Feb 2016
- First submitted
- 10 Feb 2016
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- 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
- Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)(WS)(ISNHP)
- ClinicalTrials.gov ID
- NCT02685189
- Acronym / sponsor ID
- 64,185-06LT-2
- Conditions
- Hyperbilirubinemia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study stopped for business reasons and not for any safety reasons.
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- 10 May 2016 (actual)
- Study completion
- 10 May 2016 (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.
The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion".
Detailed description
The purpose of this protocol is to provide a mechanism to collect Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion". Data on long-term impact of Stannsoporfin on the physical, neurological, neurodevelopmental, biochemical, metabolic and hematopoietic profiles of the children will be collected at 9 and 18 months, 3, 6 and 9 years after Stannsoporfin administration
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.75 mg/kg Previous exposure to stannsoporfin | – | Other: Previous exposure to stannsoporfinPrevious exposure 0.75 mg/kg |
| 1.5 mg/kg Previous exposure to stannsoporfin | – | Other: Previous exposure to stannsoporfinPrevious exposure 1.5 mg/kg |
Who may qualify
- Ages
- 1 day to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children who have been enrolled and received Stanate® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up.
Key inclusion criteria (1 listed)
- All children who have been enrolled and received Stanate® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up.
Key exclusion criteria (1 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 |
|---|---|---|
| Previous exposure to stannsoporfinNo intervention in this protocol | Other | 0.75 mg/kg Previous exposure to stannsoporfin, 1.5 mg/kg Previous exposure to stannsoporfin |
Primary outcome
NEUROLOGICAL EXAMINATION; Child Behavior Check List
Time frame: 10 years
Child Behavior Check List is a standardized measure in child psychology for evaluating maladaptive behavioral and emotional problems in preschool patients
Results and safety
The study was stopped early (reason given: Study stopped for business reasons and not for any safety reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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.
Nancy Ruiz, MD study director
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Questions about this trial
What is this clinical trial studying?
An observational study of 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: stopped early, 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 was stopped early (reason given: Study stopped for business reasons and not for any safety reasons.). Results are not available in the source record.
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?
NEUROLOGICAL EXAMINATION; Child Behavior Check List (time frame: 10 years). 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.