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

NCT ID: NCT02596997

Last Updated: 2022-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adenovirus

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brincidofovir

Up to 100mg Brincidofovir twice weekly, not to exceed a total dose of 200mg each week

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BCV CMX001

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Arkansas Medical Center

Little Rock, Arkansas, United States

Site Status

Children's Hospital LA

Los Angeles, California, United States

Site Status

UCLA Medical Center

Los Angeles, California, United States

Site Status

Children's Hospital of Orange County

Orange, California, United States

Site Status

Pediatric Stem Cell Transplantation Stanford University

Palo Alto, California, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

UC San Diego Moores Cancer center

San Diego, California, United States

Site Status

University of California San Francisco Benioff Children's Hospital

San Francisco, California, United States

Site Status

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

All Childrens Research Institute

St. Petersburg, Florida, United States

Site Status

All Children's Research Institute

St. Petersburg, Florida, United States

Site Status

Emory University-AFLAC Cancer and Blood Disorder Clinic

Atlanta, Georgia, United States

Site Status

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Children's Mercy Hospital

Kansas City, Kansas, United States

Site Status

University of Louisville-Kosair Childrens Hospital

Louisville, Kentucky, United States

Site Status

Children's Hospital New Orleans

New Orleans, Louisiana, United States

Site Status

Brigham & Woman's Hospital/Boston

Boston, Massachusetts, United States

Site Status

Michigan State/Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

University of Nebraska

Omaha, Nebraska, United States

Site Status

Hackensack University MC

Hackensack, New Jersey, United States

Site Status

Weill Conrell Medical Center

New York, New York, United States

Site Status

Morgan Stanley Children's Hospital

New York, New York, United States

Site Status

Memorial Sloan Kettering

New York, New York, United States

Site Status

New York Medical College-Maria Fareri Childrens hospital

New York, New York, United States

Site Status

The Children's Hospital at Montefiore

The Bronx, New York, United States

Site Status

New York Medical College, Maria Fareri Children's Hospital

Valhalla, New York, United States

Site Status

Levine Children's Hospital

Charlotte, North Carolina, United States

Site Status

Duke University Medical System

Durham, North Carolina, United States

Site Status

Cincinnatti Children's Hospital

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

The Childrens hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Methodist University Hospital-BMT program west clinic

Memphis, Tennessee, United States

Site Status

St. Jude Research Hospital

Memphis, Tennessee, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Cook Children's Health Care System

Fort Worth, Texas, United States

Site Status

Baylor College of Medicine-Infectious Disease

Houston, Texas, United States

Site Status

University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Methodist Children's Hospital of South Texas

San Antonio, Texas, United States

Site Status

University of Washington/ Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Medical College of Wisconsin

Wauwatosa, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CMX001-351

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.