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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01315457
Other study ID # 2009-03-006
Secondary ID
Status Completed
Phase N/A
First received March 13, 2011
Last updated May 22, 2012
Start date April 2009
Est. completion date March 2012

Study information

Verified date May 2012
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry for Health and Welfare
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 182
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 90 Years
Eligibility Inclusion Criteria:

- Patients received alemtuzumab as a treatment for hematologic malignancy ex. non-Hodgkin lymphoma Acute myeloid leukemia Aplastic anemia

Exclusion Criteria:

- Patients did not receive alemtuzumab

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms

  • Patients Treated With Alemtuzumab

Locations

Country Name City State
China Queen Mary Hospital Hong Kong
Indonesia Cipto Mangunkusumo General Hospital Jakarta
Korea, Republic of Samsung Medical Center Seoul
Taiwan National Taiwan University Hospital Teipei
Thailand Chulalongkorn University Bangkok

Sponsors (11)

Lead Sponsor Collaborator
Samsung Medical Center Asan Medical Center, Chonbuk National University, Chonnam National University, Chulalongkorn University, Dr Cipto Mangunkusumo General Hospital, Kyungpook National University, National Taiwan University Hospital, Queen Mary Hospital, Hong Kong, Soon Chun Hyang University, Yonsei University

Countries where clinical trial is conducted

China,  Indonesia,  Korea, Republic of,  Taiwan,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Infectious event Any infectious complication occurred within one year after the use of alemtuzumab one year Yes