- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00076960
Compassionate Use of Stanate (TM) [Stannsoporfin]
October 11, 2019 updated by: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
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.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 hours to 1 week (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- Term or near term neonate
- Elevated serum bilirubin
- Failing phototherapy
- Requires exchange transfusion
- Family refuses exchange transfusion on religious grounds
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 6, 2004
First Submitted That Met QC Criteria
February 9, 2004
First Posted (Estimate)
February 10, 2004
Study Record Updates
Last Update Posted (Actual)
October 15, 2019
Last Update Submitted That Met QC Criteria
October 11, 2019
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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