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Trial record 3 of 8 for:    brincidofovir adenovirus

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

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ClinicalTrials.gov Identifier: NCT02420080
Recruitment Status : Terminated (Study was terminated early due to results from previous CMX study)
First Posted : April 17, 2015
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Chimerix

Brief 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.

Condition or disease Intervention/treatment
Adenovirus 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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Retrospective
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
Study Start Date : February 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

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 Name: 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 Name: CMX001




Primary Outcome Measures :
  1. Cohort A (Time to progression of AdV disease through Week 36) [ Time Frame: 36 weeks ]
    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.


Secondary Outcome Measures :
  1. Cohort B (Time to all-cause mortality through Week 36) [ Time Frame: 36 weeks ]
    Time to all-cause mortality through Week 36 post diagnosis of disseminated AdV disease



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Ages Eligible for Study:   2 Months to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420080


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

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Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT02420080     History of Changes
Other Study ID Numbers: CMX001-305
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Adenoviridae Infections
DNA Virus Infections
Virus Diseases