A Study of the Safety and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 4/21/2016 |
| Start Date: | August 2013 |
| End Date: | September 2015 |
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study of the Safety, Tolerability, and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients
The purpose of this study is to compare the effectiveness of CMX001 to placebo for the
prevention of CMV infection in stem cell transplant patient who do not have CMV before
starting treatment with CMX001.
prevention of CMV infection in stem cell transplant patient who do not have CMV before
starting treatment with CMX001.
Inclusion Criteria:
- Subjects will be adult allogeneic HSCT recipients aged ≥ 18 years-old (or as
applicable, per local law) who were CMV seropositive before transplantation and are
CMV viremia negative posttransplant.
Exclusion Criteria:
- Subjects who have a positive CMV viremia test at any time between transplant and the
First Dose Day (FDD).
- Subjects with hypersensitivity (not renal dysfunction or eye disorder) to CDV or to
CMX001 or its excipients.
- Subjects who have received any anti-CMV therapy and investigational anti-CMV drugs at
any time posttransplant.
- Subjects who have had any anti-CMV vaccine at any time.
We found this trial at
40
sites
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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University of Miami Hospital The University of Miami changed the face of modern health care...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
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