Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

March 10, 2022 updated by: Chimerix

An Intermediate-size, Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

Provide patients with serious AdV infection or disease access to treatment with BCV.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas Medical Center
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Los Angeles, California, United States, 90027
        • Children's Hospital LA
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, United States, 94304
        • Stanford University
      • Palo Alto, California, United States, 94304
        • Pediatric Stem Cell Transplantation Stanford University
      • San Diego, California, United States, 92037
        • UC San Diego Moores Cancer Center
      • San Francisco, California, United States, 94143
        • University of California San Francisco Benioff Children's Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Saint Petersburg, Florida, United States, 33701
        • All Children's Research Institute
      • Saint Petersburg, Florida, United States, 33606
        • All Childrens Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University-AFLAC Cancer and Blood Disorder Clinic
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Kansas
      • Kansas City, Kansas, United States, 64108
        • Children's Mercy Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40292
        • University of Louisville-Kosair Childrens Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Children's Hospital New Orleans
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Woman's Hospital/Boston
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Michigan State/Spectrum Health
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68198-5400
        • University of Nebraska
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University MC
    • New York
      • Bronx, New York, United States, 10467
        • The Children's Hospital at Montefiore
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering
      • New York, New York, United States, 10021
        • Weill Conrell Medical Center
      • New York, New York, United States, 10032
        • Morgan Stanley Children's Hospital
      • New York, New York, United States, 10595
        • New York Medical College-Maria Fareri Childrens hospital
      • Valhalla, New York, United States, 10595
        • New York Medical College, Maria Fareri Children's Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Levine Children's Hospital
      • Durham, North Carolina, United States, 27710
        • Duke University Medical System
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnatti Children's Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Childrens Hospital of Philadelphia
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital-BMT program west clinic
      • Memphis, Tennessee, United States, 38105
        • St. Jude Research Hospital
    • Texas
      • Dallas, Texas, United States, 75235
        • UT Southwestern Medical Center
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Health Care System
      • Houston, Texas, United States, 77030
        • University of Texas, MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine-Infectious Disease
      • San Antonio, Texas, United States, 78229
        • Methodist Children's Hospital of South Texas
    • Washington
      • Seattle, Washington, United States, 98195
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98105
        • University of Washington/ Seattle Children's Hospital
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed serious AdV infection based on clinical symptoms and laboratory testing showing AdV in the blood or other bodily fluids
  • Able to swallow medication, either tablet or liquid

Exclusion Criteria:

  • Previous dosing with Brincidofovir
  • If female, not pregnant or trying to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chimerix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMX001-351

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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