A Multicenter Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304

A Multicenter Non-Interventional Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304

The objective is data collection to determine background rates of adenovirus (AdV) progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.

Study Overview

• Status: Terminated
• Conditions: Adenovirus
• Intervention / Treatment: Drug: Brincidofovir

Detailed Description

The objective of this retrospective data collection is to determine background rates of adenovirus (AdV) progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles
  • District of Columbia
    • Washinton, District of Columbia, United States, 20010
      • Childrens National Health System
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital of Chicago
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Children's Hospital New Orleans
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Womens Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
    • St. Louis, Missouri, United States, 63130
      • Washington University
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska
  • New York
    • Bronx, New York, United States, 10467
      • The Children's Hospital at Montefiore
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hosital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Judes Children's Research Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • University of Utah
    • Salt Lake City, Utah, United States, 84143
      • Utah Cancer Specialist LDS Hospital
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington_Fred Hutchinson Cancer Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

allogeneic hematopoietic cell transplant (HCT) recipients who were at risk of progression to disseminated AdV disease. Allogeneic hematopoietic cell transplant recipients with disseminated AdV disease

Description

Inclusion Criteria:

• Matched-control cases must be recruited from sites participating in the CMX001-304 study and meet all of the following criteria, as applicable, to be eligible for data abstraction in this non-interventional retrospective study:
• Age at time of transplant: ≥ 2 months
• Eligible matched-control subjects must meet the disease conditions of one or both of the two cohorts listed below on or after Jan 1, 2004 and prior to Mar 12, 2014. If subjects had more than one study-qualifying episode of these disease conditions on or after Jan 1, 2004 and prior to Mar 12, 2014, only the most recent qualifying episode should be included:
• Cohort A: allogeneic hematopoietic cell transplantation (HCT) recipients who were at risk of progression to disseminated AdV disease, defined as documented evidence of 1) asymptomatic AdV viremia ≥ 1,000 copies/mL, increasing, OR 2) localized AdV infection
• Cohort B: allogeneic HCT recipients with disseminated AdV disease

Exclusion Criteria:

• Prior use of BCV

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; The primary endpoint for subjects in Cohort A is time to progression of AdV disease through Week 24 post initial AdV diagnosis, with progression of AdV disease defined as time to the following outcomes: Clinical progression to probable or definitive disseminated AdV disease Death	Drug: Brincidofovir; Rates of adenovirus progression and mortality in subjects with adenovirus infection and/or disease. Sites participating in the CMX001-304 study will be asked to participate in the CMX001-305 study retrospective data collection study.; Other Names: CMX001
Cohort B; The primary endpoint for subjects in Cohort B is time to all-cause mortality through Week 36 post diagnosis of disseminated AdV disease	Drug: Brincidofovir; Rates of adenovirus progression and mortality in subjects with adenovirus infection and/or disease. Sites participating in the CMX001-304 study will be asked to participate in the CMX001-305 study retrospective data collection study.; Other Names: CMX001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort A (Time to progression of AdV disease through Week 36)	Time to progression of AdV disease through Week 36 post initial AdV diagnosis, with progression of AdV disease defined as time to the occurrence of either clinical progression to probable or definitive disseminated AdV disease or Death.	36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort B (Time to all-cause mortality through Week 36)	Time to all-cause mortality through Week 36 post diagnosis of disseminated AdV disease	36 weeks

Collaborators and Investigators

• Sponsor: Chimerix

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Estimate): January 9, 2017
• Last Update Submitted That Met QC Criteria: January 5, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Adenoviridae Infections; Anti-Infective Agents; Antiviral Agents; Brincidofovir
• Other Study ID Numbers: CMX001-305