Neonatal JaundiceNCT00076960
Compassionate Use of Stanate (TM) [Stannsoporfin]
A study testing Stanate (TM) [stannsoporfin, tin-mesoporphyrin] in people with Neonatal Jaundice and Hyperbilirubinemia, run by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company at 1 site in United States.
Trial summary
The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin] available to infants who meet the following criteria: 1. the infant has a very high level of bilirubin without an adequate clinical response to phototherapy; 2. the infant requires an exchange transfusion; and 3. Read more about this study
- Who is it for?
- Ages 12 hours to 1 week
- Conditions the study is for
- Neonatal Jaundice, Hyperbilirubinemia
- What is being tested?
- Stanate (TM) [stannsoporfin, tin-mesoporphyrin]
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 hours to 1 week
- All sexes
- No healthy volunteers
- Child
- Term or near term neonate
- Elevated serum bilirubin
- Failing phototherapy
- Requires exchange transfusion
- Family refuses exchange transfusion on religious grounds
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions
The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin] available to infants who meet the following criteria:
- the infant has a very high level of bilirubin without an adequate clinical response to phototherapy;
- the infant requires an exchange transfusion; and
- the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.
- Conditions
- Neonatal Jaundice, Hyperbilirubinemia
- Being tested
- Stanate (TM) [stannsoporfin, tin-mesoporphyrin]
- Keywords
- hyperbilirubinemia, jaundice, tin-mesoporphyrin, stannsoporfin, exchange transfusion, neonatal hyperbilirubinemia
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia, Jaundice, Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stanate (TM) [stannsoporfin, tin-mesoporphyrin]Drug
Treatment with 4.5 mg/kg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076960
- Sponsor's protocol ID
- 99A
- Status last verified
- Jan 2016
- First submitted
- 6 Feb 2004
- Last updated
- 15 Oct 2019
- Results posted
- No
Publications
Kappas A, Drummond GS, Munson DP, Marshall JR. Sn-Mesoporphyrin interdiction of severe hyperbilirubinemia in Jehovah's Witness newborns as an alternative to exchange transfusion. Pediatrics. 2001 Dec;108(6):1374-7. doi: 10.1542/peds.108.6.1374.
PubMed 11731664
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
- Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions
- ClinicalTrials.gov ID
- NCT00076960
- Acronym / sponsor ID
- 99A
- Conditions
- Neonatal Jaundice, Hyperbilirubinemia
- Keywords
- hyperbilirubinemia, jaundice, tin-mesoporphyrin, stannsoporfin, exchange transfusion, neonatal hyperbilirubinemia
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- First posted
- 10 Feb 2004 (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 make Stanate (TM) [stannsoporfin, tin-mesoporphyrin] available to infants who meet the following criteria:
- the infant has a very high level of bilirubin without an adequate clinical response to phototherapy;
- the infant requires an exchange transfusion; and
- the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.
Study design
Who may qualify
- Ages
- 12 hours to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Stanate (TM) [stannsoporfin, tin-mesoporphyrin]Treatment with 4.5 mg/kg | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Background: PubMed 11731664Kappas A, Drummond GS, Munson DP, Marshall JR. Sn-Mesoporphyrin interdiction of severe hyperbilirubinemia in Jehovah's Witness newborns as an alternative to exchange transfusion. Pediatrics. 2001 Dec;108(6):1374-7. doi: 10.1542/peds.108.6.1374.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stanate (TM) [stannsoporfin, tin-mesoporphyrin] in people with Neonatal Jaundice and Hyperbilirubinemia, 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?
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: status not confirmed, 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.
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. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00076960, which also lists 1 linked publication.
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.