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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.

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



Information from the National Library of Medicine

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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


  Show 22 Study Locations
Sponsors and Collaborators
Chimerix

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:
Adenoviridae Infections
DNA Virus Infections
Virus Diseases