Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
NCT ID: NCT01063829
Last Updated: 2018-02-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
133 participants
INTERVENTIONAL
2010-03-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Dose regimen 1
60 mg AIC246, one tablet per day
60 mg AIC246
Oral administration
Dose regimen 2
120 mg AIC246, one tablet per day
120 mg AIC246
Oral administration
Dose regimen 3
240 mg AIC246, one tablet per day
240 mg AIC246
Oral administration
Placebo
Placebo arm
Placebo
Oral administration
Interventions
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60 mg AIC246
Oral administration
120 mg AIC246
Oral administration
240 mg AIC246
Oral administration
Placebo
Oral administration
Eligibility Criteria
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Inclusion Criteria
* First allogeneic Human blood precursor cell (HBPC) transplantation performed for 1 of the following diagnoses: leukaemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, myelodysplastic and myeloproliferative disorder
* Evidence of post transplantation engraftment
* Able to swallow tablets.
Exclusion Criteria
* Mismatched or cord blood transplant recipients
* Current or history of end-organ HCMV disease
* Graft versus host disease (GVHD)
* Impaired liver function
* Reduced renal function
18 Years
ALL
No
Sponsors
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Quintiles, Inc.
INDUSTRY
AiCuris Anti-infective Cures AG
INDUSTRY
Responsible Party
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Locations
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UCLA Medical Center
Los Angeles, California, United States
Stanford University Hospital
Stanford, California, United States
Denver St. Lukes Presbyterian
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Loyola University Chicago
Maywood, Illinois, United States
Indiana BMT
Beech Grove, Indiana, United States
University Of Iowa
Iowa City, Iowa, United States
Dana Farber Cancer Institute,
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Jeanes Hospital of TUHS
Philadelphia, Pennsylvania, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Universitaetsklinikum Dresden
Dresden, , Germany
Universitaetsklinikum Erlangen-PS
Erlangen, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitaeetsklinikum Heidelberg, ,
Heidelberg, , Germany
Universitaetsklinikum Mainz
Mainz, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Klinikum Nuernberg Nord
Nuremberg, , Germany
Robert-Bosch-Krankenhaus
Stuttgart, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Countries
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References
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Chemaly RF, Ullmann AJ, Stoelben S, Richard MP, Bornhauser M, Groth C, Einsele H, Silverman M, Mullane KM, Brown J, Nowak H, Kolling K, Stobernack HP, Lischka P, Zimmermann H, Rubsamen-Schaeff H, Champlin RE, Ehninger G; AIC246 Study Team. Letermovir for cytomegalovirus prophylaxis in hematopoietic-cell transplantation. N Engl J Med. 2014 May 8;370(19):1781-9. doi: 10.1056/NEJMoa1309533.
Related Links
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Related Info
Other Identifiers
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AIC246-01-II-02
Identifier Type: -
Identifier Source: org_study_id
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