The Chimerix CMX001 Registry

Outcomes Clinical Trial

— CMX001  

Official title:

A Prospective Observational Study for the Long-term Follow-up of Subjects Previously Enrolled in Selected Clinical Studies of CMX001.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02167685
• Other study ID #: CMX001-333
• Status: Terminated
• Start date: January 2014
• Est. completion date: May 10, 2019

Study information

• Verified date: May 2019
• Source: Chimerix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 550
• Est. completion date: May 10, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Outcomes
• Survival Rates

Intervention

Drug:
• CMX001

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chimerix

Countries where clinical trial is conducted

United States,  Belgium,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to all-cause mortality	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	10 years