Phase III, Open-labeled, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection
Status: | Active, not recruiting |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any - 75 |
Updated: | 4/21/2016 |
Start Date: | March 2014 |
A Phase 3, Open-Label, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection (Chimerix Study CMX001-304)
This is a multicenter study of Brincidofovir (CMX001) (BCV) administered twice weekly (BIW)
for the treatment of AdV infection detected during asymptomatic AdV viremia or during
symptomatic AdV infection. After completing a screening assessment to confirm study
eligibility, all enrolled subjects will undergo a treatment period of 12 weeks. Beginning on
Day 1, adult (≥ 18 years) and adolescent (13-17 years) subjects weighing > 50 kg will
receive BCV 100 mg BIW; children up to 12 years of age will receive weight-based doses of 2
mg/kg BIW, not-to-exceed a total dose of 200 mg/week.
for the treatment of AdV infection detected during asymptomatic AdV viremia or during
symptomatic AdV infection. After completing a screening assessment to confirm study
eligibility, all enrolled subjects will undergo a treatment period of 12 weeks. Beginning on
Day 1, adult (≥ 18 years) and adolescent (13-17 years) subjects weighing > 50 kg will
receive BCV 100 mg BIW; children up to 12 years of age will receive weight-based doses of 2
mg/kg BIW, not-to-exceed a total dose of 200 mg/week.
Inclusion Criteria:
- Patients who have undergone hematopoietic cell transplant (HCT), solid organ
transplant (SOT)
- Have a primary or other severe immunodeficiency which predisposes to rapid
progression to disseminated AdV disease
- Must be able to ingest, absorb and tolerate oral medication
- Willing and able to understand and provide written informed consent. For minors or
those incapable of providing written informed consent (i.e., incapacitated),
understood, written and informed consent must be provided by a parent or legal
guardian or representative.
- To the best of his or her (or parent/guardian) knowledge, willing and able to
participate in all required study activities for the duration of the study.
Exclusion Criteria:
- Females who are pregnant or currently nursing.
- Patients with any other condition that would, in the judgment of the investigator,
put the patient at increased risk during participation in the study, or interfere
with the conduct of the study.
We found this trial at
34
sites
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
Click here to add this to my saved trials
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
Click here to add this to my saved trials
University of Chicago One of the world's premier academic and research institutions, the University of...
Click here to add this to my saved trials
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
Click here to add this to my saved trials
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
Click here to add this to my saved trials
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
Click here to add this to my saved trials
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
Click here to add this to my saved trials
Click here to add this to my saved trials
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
Click here to add this to my saved trials
Click here to add this to my saved trials
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
Click here to add this to my saved trials
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
Click here to add this to my saved trials
Click here to add this to my saved trials
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
Click here to add this to my saved trials
Click here to add this to my saved trials