Clinical trial NCT02167685: The Chimerix CMX001 Registry
Official title: A Prospective Observational Study for the Long-term Follow-up of Subjects Previously Enrolled in Selected Clinical Studies of CMX001.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Outcomes
Survival Rates
Lead sponsor: Chimerix
Sponsor class: INDUSTRY
First posted: 2014-06-19
Enrollment: 550
Sex: ALL
Minimum age (years): 6
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects previously enrolled in selected clinical studies of CMX001

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to all-cause mortality
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: St. Vincent Medical Center
state: California
city: Los Angeles
country: United States
facility: Children's Hospital of LA
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Childrens Hospital of Colorado
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital/Health Science Center
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute Emory University
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University School of Medicine
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: New Orleans
country: United States
facility: Children's Hospital of New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital/Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Harper University Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Children Mercy Hospital and Clinics
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack
state: New Jersey
city: Bronx
country: United States
facility: Albert Einstein Cancer Center at Montefiore Medical Park
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mt Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weil Cornell Medical Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny-Singer Cancer Institute
state: Pennsylvania
city: Memphis
country: United States
facility: St. Judes Children's Hospital
state: Tennessee
city: Dallas
country: United States
facility: Baylor Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas-MD Anderson
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare System
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Intermountain Center for Hematological Malignancies
state: Utah
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Liege
country: Belgium
facility: Centre Hospitalier Unversitaire Sart
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosement
state: Quebec
Study officials:
References: