The Chimerix CMX001 Registry (CMX001)

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

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.

Study Overview

• Status: Terminated
• Conditions: Outcomes; Survival Rates
• Intervention / Treatment: Drug: CMX001

• Study Type: Observational
• Enrollment (Anticipated): 550

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint Luc
  • Liege, Belgium
    • Centre Hospitalier Unversitaire Sart
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • University of Toronto
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve-Rosement
• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California San Diego
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
    • Los Angeles, California, United States, 90027
      • Children's Hospital of LA
    • Los Angeles, California, United States, 90006
      • St. Vincent Medical Center
    • Palo Alto, California, United States, 94305
      • Stanford University
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital/Health Science Center
    • Aurora, Colorado, United States, 80045
      • Childrens Hospital of Colorado
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
    • Atlanta, Georgia, United States, 30306
      • Emory University
    • Atlanta, Georgia, United States, 30306
      • Winship Cancer Institute Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60611
      • Northwestern University School Of Medicine
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Children's Hospital of New Orleans
  • Maryland
    • Baltimore, Maryland, United States, 44195
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital/Dana Farber Cancer Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201
      • Harper University Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children Mercy Hospital and Clinics
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Bronx, New York, United States, 10467
      • Albert Einstein Cancer Center at Montefiore Medical Park
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10065
      • Weil Cornell Medical Center
    • New York, New York, United States, 10029
      • Mt Sinai
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Winston-Salem, North Carolina, United States, 27517
      • Wake Forest University Baptist Center
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care, Inc
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15224
      • Allegheny-Singer Cancer Institute
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Judes Children's Hospital
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Cancer Center
    • Houston, Texas, United States, 77030
      • University of Texas-MD Anderson
    • San Antonio, Texas, United States, 78229
      • Methodist Healthcare System
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
    • Salt Lake City, Utah, United States, 84113
      • University of Utah
    • Salt Lake City, Utah, United States, 84143
      • Intermountain Center for Hematological Malignancies
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects previously enrolled in selected clinical studies of CMX001

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CMX001; Subjects who have previously participated in CMX001-301 or other CMX001 study.	Drug: CMX001; Other Names: Brincidofovir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chimerix

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 10, 2019
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: June 17, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (Estimate): June 19, 2014

Study Record Updates

• Last Update Posted (Actual): May 17, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Brincidofovir
• Other Study ID Numbers: CMX001-333