OutcomesCMX001NCT02167685
The Chimerix CMX001 Registry
An observational study of Outcomes and Survival Rates, run by Jazz Pharmaceuticals at 51 sites in 3 countries.
Trial summary
The prospective observational study is to establish a registry database to evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as outcomes, late CMV and other Double-stranded DNA virus associated events, s well as survival rates in subjects previously… Read more about this study
- Who is it for?
- Ages 6 months to 100 years
- Conditions the study is for
- Outcomes, Survival Rates
- What is being tested?
- CMX001
- How many people
- 550 participants
- Where
- 51 sitesin 3 countries
- Study dates
- Jan 2014to 10 May 2019
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 6 months to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects previously enrolled in selected clinical studies of CMX001
Who may be able to join
- Have previously completed study CMX001-301 through the Week 24 visit, or participated in another qualifying clinical study with CMX001.
- Willing and able to understand and provide written informed consent to participate in this observational study
- Willing and able to participate in all required study activities for the entire duration of the observational study (i.e., agreeable to being contacted at periodic intervals over the course of approximately 10 years following the completion of study CMX001-301 or other qualifying clinical study.
Who cannot join
- None
Trial locations and contacts
51 sites in 3 countries.
51 sites in 3 countries
United States47 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30306
Winship Cancer Institute Emory University
Atlanta, Georgia, 30306
Northside Hospital
Atlanta, Georgia, 30342
Childrens Hospital of Colorado
Aurora, Colorado, 80045
University of Colorado Denver
Aurora, Colorado, 80045
University of Colorado Hospital/Health Science Center
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 44195
Brigham and Women's Hospital/Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Northwestern University School of Medicine
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45229
Oncology Hematology Care, Inc
Cincinnati, Ohio, 45242
Baylor Cancer Center
Dallas, Texas, 75246
Harper University Hospital
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
Hackensack
Hackensack, New Jersey, 07601
University of Texas-MD Anderson
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Children Mercy Hospital and Clinics
Kansas City, Missouri, 64108
University of California San Diego
La Jolla, California, 92093
St. Vincent Medical Center
Los Angeles, California, 90006
Children's Hospital of LA
Los Angeles, California, 90027
UCLA Medical Center
Los Angeles, California, 90095
St. Judes Children's Hospital
Memphis, Tennessee, 38105
University of Miami
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55455
Yale University
New Haven, Connecticut, 06519
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118
Mt Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weil Cornell Medical Center
New York, New York, 10065
University of Nebraska
Omaha, Nebraska, 68198
Stanford University
Palo Alto, California, 94305
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Allegheny-Singer Cancer Institute
Pittsburgh, Pennsylvania, 15224
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of Utah
Salt Lake City, Utah, 84113
Intermountain Center for Hematological Malignancies
Salt Lake City, Utah, 84143
Methodist Healthcare System
San Antonio, Texas, 78229
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
Albert Einstein Cancer Center at Montefiore Medical Park
The Bronx, New York, 10467
Montefiore Medical Center
The Bronx, New York, 10467
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Wake Forest University Baptist Center
Winston-Salem, North Carolina, 27517
Belgium2 sites
Cliniques Universitaires Saint Luc
Brussels, 1200
Centre Hospitalier Unversitaire Sart
Liège
Canada2 sites
Hopital Maisonneuve-Rosement
Montreal, Quebec, H1T 2M4
University of Toronto
Toronto, Ontario, M5G 2C4
About this study
Official title: A Prospective Observational Study for the Long-term Follow-up of Subjects Previously Enrolled in Selected Clinical Studies of CMX001.
The prospective observational study is to establish a registry database to evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as outcomes, late CMV and other Double-stranded DNA virus associated events, s well as survival rates in subjects previously enrolled in selected clinical studies of CMX001. Each Registry participant will be followed for a period of approximately 3 years from their enrollment in the Registry.
- Conditions
- Outcomes, Survival Rates
- Being tested
- CMX001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMX001Drug
Also called Brincidofovir
| Study group | Role | What they receive |
|---|---|---|
| CMX001 | Subjects who have previously participated in CMX001-301 or other CMX001 study. Receives: Drug: CMX001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to all-cause mortality
evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as the development of new malignancies and late cytomegalovirus (CMV)-associated events, as well as survival rates in subjects previously enrolled in selected clinical studies of CMX001
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startJan 2014
- Primary completion10 May 2019
- Study completion10 May 2019
Why it stopped: terminated due to low enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OutcomesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167685
- Sponsor's protocol ID
- CMX001-333
- Acronym
- CMX001
- Status last verified
- May 2019
- First submitted
- 17 Jun 2014
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study for the Long-term Follow-up of Subjects Previously Enrolled in Selected Clinical Studies of CMX001.
- ClinicalTrials.gov ID
- NCT02167685
- Acronym / sponsor ID
- CMX001 / CMX001-333
- Conditions
- Outcomes, Survival Rates
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: terminated due to low enrollment rate
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 19 Jun 2014 (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.
The prospective observational study is to establish a registry database to evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as outcomes, late CMV and other Double-stranded DNA virus associated events, s well as survival rates in subjects previously enrolled in selected clinical studies of CMX001. Each Registry participant will be followed for a period of approximately 3 years from their enrollment in the Registry.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMX001 | – | Drug: CMX001Subjects who have previously participated in CMX001-301 or other CMX001 study. |
Who may qualify
- Ages
- 6 months to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects previously enrolled in selected clinical studies of CMX001
Key inclusion criteria (3 listed)
- Have previously completed study CMX001-301 through the Week 24 visit, or participated in another qualifying clinical study with CMX001.
- Willing and able to understand and provide written informed consent to participate in this observational study
- Willing and able to participate in all required study activities for the entire duration of the observational study (i.e., agreeable to being contacted at periodic intervals over the course of approximately 10 years following the completion of study CMX001-301 or other qualifying clinical study.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| CMX001Also: Brincidofovir | Drug | CMX001 |
Primary outcome
Time to all-cause mortality
Time frame: 10 years
evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as the development of new malignancies and late cytomegalovirus (CMV)-associated events, as well as survival rates in subjects previously enrolled in selected clinical studies of CMX001
Results and safety
The study was stopped early (reason given: terminated due to low enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
Related trials for Outcomes
RecruitingObservational study
Treatment Effectiveness in People With axSpA or PsA Starting Treatment With Bimekizumab, Risankizumab, Guselkumab, Upadacitinib, or a TNF Inhibitor
Axial Spondylarthritis (axSpA), Psoriatic Arthritis (PsA)
Not yet recruiting
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Nitric Oxide
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Recruiting
Aquatic Versus Land-Based Exercise in Women With Lipedema
Lipedema
Not yet recruitingObservational study
Development and Validation of a Chinese Quality of Life Scale for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH), Quality of Life
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.
51 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outcomes and Survival Rates, run by Jazz Pharmaceuticals at 51 sites in 3 countries.
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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Belgium, Canada. 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?
The study was stopped early (reason given: terminated due to low enrollment rate). 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.
What does the primary outcome measure?
Time to all-cause mortality (time frame: 10 years). It is what the study was designed to measure, not a finding.
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 17 May 2019.