Trial record 1 of 8 for:
brincidofovir adenovirus
Phase III, Open-labeled, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection (CMX001 Adv)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02087306 |
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Recruitment Status :
Completed
First Posted : March 14, 2014
Last Update Posted : November 11, 2016
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Sponsor:
Chimerix
Information provided by (Responsible Party):
Chimerix
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adenovirus Infection | Drug: CMX001 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 201 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Study Start Date : | March 2014 |
| Actual Primary Completion Date : | June 2016 |
| Actual Study Completion Date : | August 2016 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: CMX001 |
Drug: CMX001
CMX001 administered twice weekly, dose depending on weight.
Other Name: Brincidofovir |
Primary Outcome Measures :
- To compare the overall mortality at Week 24 of subjects treated with BCV during asymptomatic adenovirus (AdV) viremia or "early" AdV infection to the mortality at Week 24 for subjects treated with BCV during symptomatic or "late" AdV disease [ Time Frame: 24 weeks ]To compare the overall mortality at Week 24 of subjects treated with BCV during asymptomatic adenovirus (AdV) viremia or "early" AdV infection to the mortality at Week 24 for subjects treated with BCV during symptomatic or "late" AdV disease
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| Ages Eligible for Study: | 2 Months to 75 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087306
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Locations
| United States, Arizona | |
| Phoenix Children's Hospital | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Stanford Children's Hospital | |
| Palo Alto, California, United States, 94305 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| Children's Hospital Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, District of Columbia | |
| Children's National Health System | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Georgia | |
| Children's Healthcare of Atlanta, Aflac Cancer and Blood Center | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Ann & Robert H. Lurie Children's Hospital of Chicago | |
| Chicago, Illinois, United States, 60611 | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Louisiana | |
| Children's Hospital | |
| New Orleans, Louisiana, United States, 70118 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Brigham and Woman's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| University of Nebraska | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New York | |
| Montifore Medical Center | |
| Bronx, New York, United States, 10467 | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Weill Cornell Medical College/ New York Presbyterian Hospital | |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Levine Children's Hospital | |
| Charlotte, North Carolina, United States, 28203 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27712 | |
| United States, Ohio | |
| Cincinnatti Children's Hospital | |
| Cincinnatti, Ohio, United States, 45229 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Tennessee | |
| St. Jude Children's Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| United States, Texas | |
| Cook Children's Medical Center | |
| Fort Worth, Texas, United States, 76104 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Intermountain Healthcare Research | |
| Salt Lake City, Utah, United States, 84103 | |
| University of Utah Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Washington | |
| Fred Hutchingson Cancer Center | |
| Seattle, Washington, United States, 19024 | |
| Seattle Children's Hospital | |
| Seattle, Washington, United States, 98105 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
Chimerix
| Responsible Party: | Chimerix |
| ClinicalTrials.gov Identifier: | NCT02087306 History of Changes |
| Other Study ID Numbers: |
CMX001 304 |
| First Posted: | March 14, 2014 Key Record Dates |
| Last Update Posted: | November 11, 2016 |
| Last Verified: | August 2015 |
Keywords provided by Chimerix:
|
Adenovirus Infection |
Additional relevant MeSH terms:
|
Infection Communicable Diseases Adenoviridae Infections DNA Virus Infections Virus Diseases |