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

Adenovirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02420080
• Other study ID #: CMX001-305
• Status: Terminated
• Phase: N/A
• First received: April 9, 2015
• Last updated: January 5, 2017
• Start date: February 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Chimerix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 75 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adenoviridae Infections
• Adenovirus

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Brigham and Womens Hospital	Boston	Massachusetts
United States	The Children's Hospital at Montefiore	Bronx	New York
United States	Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hosital	Cincinnati	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	St. Judes Children's Research Hospital	Memphis	Tennessee
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Children's Hospital New Orleans	New Orleans	Louisiana
United States	Memorial Sloan Kettering	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	Utah Cancer Specialist LDS Hospital	Salt Lake City	Utah
United States	University of Washington_Fred Hutchinson Cancer Center	Seattle	Washington
United States	Washington University	St. Louis	Missouri
United States	Childrens National Health System	Washinton	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Chimerix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No