MedPath

The Chimerix CMX001 Registry

Terminated
Conditions
Outcomes
Survival Rates
Interventions
Registration Number
NCT02167685
Lead Sponsor
Chimerix
Brief Summary

The prospective observational study is to establish a registry database to evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as outcomes, late CMV and other Double-stranded DNA virus associated events, s well as survival rates in subjects previously enrolled in selected clinical studies of CMX001. Each Registry participant will be followed for a period of approximately 3 years from their enrollment in the Registry.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
550
Inclusion Criteria
  • Have previously completed study CMX001-301 through the Week 24 visit, or participated in another qualifying clinical study with CMX001.
  • Willing and able to understand and provide written informed consent to participate in this observational study
  • Willing and able to participate in all required study activities for the entire duration of the observational study (i.e., agreeable to being contacted at periodic intervals over the course of approximately 10 years following the completion of study CMX001-301 or other qualifying clinical study.
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
CMX001CMX001Subjects who have previously participated in CMX001-301 or other CMX001 study.
Primary Outcome Measures
NameTimeMethod
Time to all-cause mortality10 years

evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as the development of new malignancies and late cytomegalovirus (CMV)-associated events, as well as survival rates in subjects previously enrolled in selected clinical studies of CMX001

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (51)

Children's Hospital of LA

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Los Angeles, California, United States

Emory University

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Atlanta, Georgia, United States

Winship Cancer Institute Emory University

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Atlanta, Georgia, United States

Hackensack

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Hackensack, New Jersey, United States

Northwestern University School of Medicine

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Chicago, Illinois, United States

Brigham and Women's Hospital/Dana Farber Cancer Institute

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Boston, Massachusetts, United States

University of Texas-MD Anderson

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Houston, Texas, United States

University of Miami

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Miami, Florida, United States

Methodist Healthcare System

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San Antonio, Texas, United States

St. Vincent Medical Center

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Los Angeles, California, United States

UCLA Medical Center

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Los Angeles, California, United States

Washington University School of Medicine

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Saint Louis, Missouri, United States

University of Chicago

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Chicago, Illinois, United States

St. Judes Children's Hospital

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Memphis, Tennessee, United States

University of Iowa Hospitals and Clinics

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Iowa City, Iowa, United States

Johns Hopkins University

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Baltimore, Maryland, United States

University of Minnesota

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Minneapolis, Minnesota, United States

Mt Sinai

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New York, New York, United States

Albert Einstein Cancer Center at Montefiore Medical Park

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Bronx, New York, United States

Memorial Sloan Kettering Cancer Center

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New York, New York, United States

Duke University

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Durham, North Carolina, United States

Weil Cornell Medical Center

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New York, New York, United States

Oncology Hematology Care, Inc

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Cincinnati, Ohio, United States

Baylor Cancer Center

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Dallas, Texas, United States

Allegheny-Singer Cancer Institute

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Pittsburgh, Pennsylvania, United States

Cincinnati Children's Medical Center

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Cincinnati, Ohio, United States

Fred Hutchinson Cancer Research Center

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Seattle, Washington, United States

Cliniques Universitaires Saint Luc

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Brussels, Belgium

University of Toronto

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Toronto, Ontario, Canada

Centre Hospitalier Unversitaire Sart

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Liege, Belgium

Hopital Maisonneuve-Rosement

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Montreal, Quebec, Canada

Harper University Hospital

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Detroit, Michigan, United States

Huntsman Cancer Institute

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Salt Lake City, Utah, United States

Henry Ford Hospital

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Detroit, Michigan, United States

Intermountain Center for Hematological Malignancies

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Salt Lake City, Utah, United States

University of Utah

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Salt Lake City, Utah, United States

University of Colorado Hospital/Health Science Center

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Aurora, Colorado, United States

Childrens Hospital of Colorado

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Aurora, Colorado, United States

University of Colorado Denver

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Aurora, Colorado, United States

The Children's Hospital of Philadelphia

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Philadelphia, Pennsylvania, United States

University of California San Diego

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La Jolla, California, United States

Stanford University

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Palo Alto, California, United States

Northside Hospital

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Atlanta, Georgia, United States

Children's National Medical Center

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Washington, District of Columbia, United States

University of Nebraska

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Omaha, Nebraska, United States

Yale University

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New Haven, Connecticut, United States

Children's Hospital of New Orleans

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New Orleans, Louisiana, United States

University of Michigan Health System

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Ann Arbor, Michigan, United States

Children Mercy Hospital and Clinics

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Kansas City, Missouri, United States

Wake Forest University Baptist Center

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Winston-Salem, North Carolina, United States

Montefiore Medical Center

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Bronx, New York, United States

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