Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA Viruses
Public ClinicalTrials.gov record NCT01143181. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open-label Study of CMX001 Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA Viruses
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was a multicenter, open-label study of oral brincidofovir (BCV) treatment of serious disease or conditions caused by double-stranded DNA (dsDNA) virus(es). Subjects received either a weight-based or a fixed dose of oral BCV once weekly (QW) or twice weekly (BIW) for up to 3 months until clinical disease was resolved or stabilized and/or viral DNA by polymerase chain reaction testing was negative for 4 consecutive weeks, whichever was longer. Under the first protocol amendment, adults and adolescents (≥13 years) received 200 mg or 300 mg BCV BIW (not to exceed 4 mg/kg total weekly dose) depending on the difficulty of treating their disease (i.e., Group 1 or Group 2, respectively), and pediatric subjects (≤12 years) received 4 mg/kg BCV BIW. Under the second protocol amendment, adults and adolescents (≥13 years), regardless of viral infection/disease, had a maximum weekly dose of 200 mg, i.e., 200 mg QW or 100 mg BIW; not to exceed 4mg/kg total weekly dose. Pediatric subjects (≤12 years), regardless of viral infection/disease, had a maximum weekly dose of 4 mg/kg, i.e., 4 mg/kg QW or 2 mg/kg BIW; not to exceed 200 mg.
Study identification
- NCT ID
- NCT01143181
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 210 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2010
- Primary completion
- Nov 30, 2012
- Completion
- Nov 30, 2012
- Last update posted
- Aug 11, 2021
2010 – 2012
United States locations
- U.S. sites
- 37
- U.S. states
- 22
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loma Linda University Hospital | Loma Linda | California | 92354 | — |
| Children's Hospital of LA | Los Angeles | California | 90027 | — |
| UCLA Department of Medicine | Los Angeles | California | 90095 | — |
| CHOC Children's | Orange | California | 92868 | — |
| Univeristy of San Francisco | San Francisco | California | 94143 | — |
| Lucile Packard Children's Hospital | Stanford | California | 94304 | — |
| Children's Hospital of Colorado | Aurora | Colorado | 80045 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Childrens Hospital LSU | New Orleans | Louisiana | 70118 | — |
| NIH | Bethesda | Maryland | 20892 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-5130 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Mt. Sinai | New York | New York | 10029 | — |
| Columbia University | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Institute | New York | New York | 10065 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Levine Children's Hospital Carolina Medical Center | Charlotte | North Carolina | 28203 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cincinnati Childrens Hospital | Cincinnati | Ohio | 45229 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| Childrens Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104-2796 | — |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Intermountain BMT program LDS Hospital | Salt Lake City | Utah | 84143 | — |
| University of Washington-Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01143181, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 11, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01143181 live on ClinicalTrials.gov.