A Randomized, Placebo-Controlled Multi-Site Phase 2 Study Evaluation the Safety and Efficacy of Preemptive Treatment With CMX001 for the Prevention of Adenovirus Disease Following Hematopoietic Stem Cell Transplantation in Adults and Children
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The primary objective of this study is to evaluate the safety and efficacy of preemptive treatment with CMX001 versus placebo for the prevention of AdV disease in recipients of HSCT with asymptomatic AdV viremia
The outcome measure for the primary endpoint will be "treatment failure". Treatment failure is a composite endpoint consisting of: Progression to probable or definitive AdV disease. OR increasing AdV viremia during randomized therapy (defined as increase from baseline in AdV viremia by ≥ 1 log10, confirmed on a second measurement, at least one week apart) AND requiring discontinuation from randomized therapy
Yes
United States: Food and Drug Administration
CMX001-202
NCT01241344
November 2010
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
New York Medical College | Valhalla, New York 10595 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania 15213 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Methodist Hospital | Houston, Texas 77030 |
University of California, San Francisco | San Francisco, California 94143 |
Children's Hospital of Alabama | Birmingham, Alabama 35233 |
Duke University Medical Center | Durham, North Carolina 27710 |
Cleveland Clinic | Cleveland, Ohio 44195 |
Indiana University | Indianapolis, Indiana 46202 |
The Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Memorial Sloan Kettering | New York, New York 10021 |
UT Southwestern | Dallas, Texas 75390 |
Cincinnati Childrens Hospital | Cincinnati, Ohio 45229 |
Pheonix Children's Hospital | Pheonix, Arizona 85016 |
Childrens hospital of LA | Los Angeles, California 90033 |
CHOC Children's Hospital | Orange, California 92868 |
Lucile Packard Childrens hopsital at Stanford | Stanford, California 94304 |
The Children's Hospital-Denver | Aurora, Colorado 80045 |
LSU Health Sciences Center New Orleans Childrens Hospital | New Orleans, Louisiana 70118 |
Harvard-Children's Hospital Boston | Boston, Massachusetts 02115 |
Univeristy of Minnesota | Minneapolis, Minnesota 55455 |
St. Louis Children's Hosptial | St. Louis, Missouri 63110 |
St. Judes Children's Research Hospital | Memphis, Tennessee 38105 |
Baylor College of Medicine, Texas Childrens Hospital | Houston, Texas 77030 |
Primary Children's Medical of Utah | Salt Lake City, Utah 84113 |