Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA Viruses

ClinicalTrials.gov ID: NCT01143181

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.

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ClinicalTrials.gov public records Last synced Oct 20, 2026, 1:09 AM EDT

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
Lead sponsor: Jazz Pharmaceuticals; Industry
Enrollment: 210 participants

Conditions and interventions

Conditions

Double-stranded DNA Virus

Interventions

Brincidofovir Drug

Drug

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: Dec 2010 (Actual)
Primary completion: Dec 2012 (Actual)
Completion: Dec 2012 (Actual)
Last update posted: Aug 12, 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 12, 2021 · Synced Oct 20, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01143181 live on ClinicalTrials.gov.

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