- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00195195
Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries
January 26, 2012 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Rapamune Follow-up Registry in Transplant Recipients in the Nordic Countries, "Wrap-up"
The purpose of this study is to gather information about the long-term effects and safety of treatment with Rapamune in transplant patients.
Study Overview
Study Type
Observational
Enrollment (Actual)
66
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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Gothenburg, Sweden, SE-413 45
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Stockholm, Sweden, SE-141 86
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Uppsala, Sweden, SE-751 85
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Transplantation patients treated with sirolimus.
Description
Inclusion Criteria:
- Transplantation patients treated with sirolimus (Rapamune).
Exclusion Criteria:
- Patients must be able to give informed consent.
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Sirolimus
|
Transplantation patients treated with sirolimus who consent to participate in the study (register)
Other Names:
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Collaborators and Investigators
This is where you will find people and organizations involved with this 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 Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
January 31, 2012
Last Update Submitted That Met QC Criteria
January 26, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0468-101157
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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