AdenovirusNCT02596997
Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease
A study testing Brincidofovir in people with Adenovirus, run by Jazz Pharmaceuticals at 46 sites in United States.
Trial summary
Provide patients with serious AdV infection or disease access to treatment with BCV. Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Adenovirus
- What is being tested?
- Brincidofovir
- How many people
- Not given
- Where
- 46 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous dosing with Brincidofovir
- If female, not pregnant or trying to become pregnant
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Emory University-AFLAC Cancer and Blood Disorder Clinic
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
Brigham & Woman's Hospital/Boston
Boston, Massachusetts, 02115
Levine Children's Hospital
Charlotte, North Carolina, 28203
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Cincinnatti Children's Hospital
Cincinnati, Ohio, 45229
Cleveland Clinic
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
UT Southwestern Medical Center
Dallas, Texas, 75235
Duke University Medical System
Durham, North Carolina, 27710
Cook Children's Health Care System
Fort Worth, Texas, 76104
University of Florida
Gainesville, Florida, 32610
Michigan State/Spectrum Health
Grand Rapids, Michigan, 49503
Hackensack University MC
Hackensack, New Jersey, 07601
Baylor College of Medicine-Infectious Disease
Houston, Texas, 77030
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Children's Mercy Hospital
Kansas City, Kansas, 64108
University of Arkansas Medical Center
Little Rock, Arkansas, 72205
Children's Hospital LA
Los Angeles, California, 90027
UCLA Medical Center
Los Angeles, California, 90095
University of Louisville-Kosair Childrens Hospital
Louisville, Kentucky, 40292
Methodist University Hospital-BMT program west clinic
Memphis, Tennessee, 38104
St. Jude Research Hospital
Memphis, Tennessee, 38105
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Weill Conrell Medical Center
New York, New York, 10021
Morgan Stanley Children's Hospital
New York, New York, 10032
Memorial Sloan Kettering
New York, New York, 10065
New York Medical College-Maria Fareri Childrens hospital
New York, New York, 10595
University of Nebraska
Omaha, Nebraska, 68198-5400
Children's Hospital of Orange County
Orange, California, 92868
Pediatric Stem Cell Transplantation Stanford University
Palo Alto, California, 94304
Stanford University
Palo Alto, California, 94304
The Childrens hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
UC San Diego Moores Cancer center
San Diego, California, 92037
University of California San Francisco Benioff Children's Hospital
San Francisco, California, 94143
University of Washington/ Seattle Children's Hospital
Seattle, Washington, 98105
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98195
Washington University
St Louis, Missouri, 63130
All Childrens Research Institute
St. Petersburg, Florida, 33606
All Children's Research Institute
St. Petersburg, Florida, 33701
The Children's Hospital at Montefiore
The Bronx, New York, 10467
New York Medical College, Maria Fareri Children's Hospital
Valhalla, New York, 10595
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Medical College of Wisconsin
Wauwatosa, Wisconsin, 53226
About this study
Official title: 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.
- Conditions
- Adenovirus
- Being tested
- Brincidofovir
- Keywords
- Adenovirus Brincidofovir
- Medical subject headings
- Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrincidofovirDrug
Also called BCV CMX001
Up to 100mg Brincidofovir twice weekly, not to exceed a total dose of 200mg each week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenovirusStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596997
- Sponsor's protocol ID
- CMX001-351
- Status last verified
- Feb 2020
- First submitted
- 3 Nov 2015
- Last updated
- 14 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intermediate-size, Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease
- ClinicalTrials.gov ID
- NCT02596997
- Acronym / sponsor ID
- CMX001-351
- Conditions
- Adenovirus
- Keywords
- Adenovirus Brincidofovir
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Provide patients with serious AdV infection or disease access to treatment with BCV.
Study design
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Previous dosing with Brincidofovir
- If female, not pregnant or trying to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrincidofovirAlso: BCV CMX001Up to 100mg Brincidofovir twice weekly, not to exceed a total dose of 200mg each week | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brincidofovir in people with Adenovirus, run by Jazz Pharmaceuticals at 46 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.