Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries
NCT00195195
Last updated date
ABOUT THIS STUDY
The purpose of this study is to gather information about the long-term effects and safety of
treatment with Rapamune in transplant patients.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Transplantation patients treated with sirolimus (Rapamune).
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Patients must be able to give informed consent.
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TransplantationStudy Evaluating Rapamune in Transplant Recipients in the Nordic Countries
NCT00195195
- Gothenburg,
- Stockholm,
- Uppsala,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries | |||
| Official Title | A Rapamune Follow-up Registry in Transplant Recipients in the Nordic Countries, "Wrap-up" | |||
| Brief Summary | The purpose of this study is to gather information about the long-term effects and safety of treatment with Rapamune in transplant patients. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Transplantation patients treated with sirolimus. | |||
| Condition | Transplantation | |||
| Intervention | Drug: Sirolimus
Transplantation patients treated with sirolimus who consent to participate in the study (register) Other Name: Rapamune | |||
| Study Groups/Cohorts | 1
Sirolimus Intervention: Drug: Sirolimus | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 66 | |||
| Original Enrollment | 200 | |||
| Actual Study Completion Date | June 2008 | |||
| Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | Child, Adult, Older Adult | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Sweden | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00195195 | |||
| Other Study ID Numbers | 0468-101157 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | January 2012 | |||