Overview

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

Status:
Terminated

Trial end date:
2016-09-01

Target enrollment:
0

Participant gender:
All

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.

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Chimerix

Treatments:

Brincidofovir

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