Infections Associated With the Use of Alemtuzumab
This study has been completed.
Sponsor:
Samsung Medical Center
Collaborators:
National Taiwan University Hospital
Cipto Mangunkusumo General Hospital
Asan Medical Center
Soon Chun Hyang University
Chonnam National University
Chonbuk National University
Chulalongkorn University
Queen Mary Hospital, Hong Kong
Yonsei University
Kyungpook National University
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01315457
First received: March 13, 2011
Last updated: May 22, 2012
Last verified: May 2012
| Tracking Information | |||||
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| First Received Date ICMJE | March 13, 2011 | ||||
| Last Updated Date | May 22, 2012 | ||||
| Start Date ICMJE | April 2009 | ||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Infectious event [ Time Frame: one year ] [ Designated as safety issue: Yes ] Any infectious complication occurred within one year after the use of alemtuzumab |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01315457 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Infections Associated With the Use of Alemtuzumab | ||||
| Official Title ICMJE | Asian Multinational Retrospective Analysis for Infectious Complications in Patients Treated With Alemtuzumab | ||||
| Brief Summary | The aim of this study is to propose infection prophylaxis from Asian multinational retrospective analysis of infectious complications in patients who were treated with alemtuzumab |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients received alemtuzumab as a treatment for hematologic malignancy |
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| Condition ICMJE | Patients Treated With Alemtuzumab | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Alemtuzumab
Patients treated with alemtuzumab |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 182 | ||||
| Completion Date | March 2012 | ||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China, Indonesia, Korea, Republic of, Taiwan, Thailand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01315457 | ||||
| Other Study ID Numbers ICMJE | 2009-03-006 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Won Seog Kim, Samsung Medical Center | ||||
| Study Sponsor ICMJE | Samsung Medical Center | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Samsung Medical Center | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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