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Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection

A Phase 3, Open-Label, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection

NCT02087306•Jazz Pharmaceuticals

View on ClinicalTrials.gov

Summary

This was a Phase 3 open-label, non-randomized, multicenter study of oral brincidofovir (BCV) administered twice weekly for the treatment of adenovirus (AdV) infection detected during asymptomatic AdV viremia or during symptomatic AdV infection.

Detailed Description

This was a Phase 3 open-label, non-randomized, multicenter study of the safety, tolerability, and efficacy of oral brincidofovir (BCV) when administered twice weekly for the treatment of disseminated adenovirus (AdV) disease and for the treatment of AdV infection when treatment was initiated in subjects who were at risk of progression to disseminated disease (i.e., during the asymptomatic or localized phases of infection).

Eligibility

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Were male or female, aged 2 months or older.
•2. Had either of the following:
•* Disseminated adenovirus (AdV) disease; or
•* An underlying immunocompromised state and were at risk of progression to disseminated AdV disease.
•\[Note: Subjects with symptomatic AdV infection (i.e., localized or disseminated AdV disease) could have been screening immediately, with brincidofovir (BCV) therapy initiated after receipt of the screening virology results from the designated central virology laboratory confirming study eligibility. Subjects with asymptomatic AdV infection (i.e., had no symptoms of AdV disease) could have been consented and screened only if they had at least 1 positive or detectable AdV DNA (quantitative \[q\]) polymerase chain reaction (PCR) test (in any blood fluid or compartment) from the local virology laboratory, with treatment initiated only after confirmation of AdV positivity by 2 separate measurements at the designated central virology laboratory. Where the results from 2 AdV DNA (q)PCR measurements in plasma or non-plasma body fluid or compartment were needed to show that a subject was at risk of progression to disseminated AdV disease, the second measurement had to be resulted prior to the initiation of BCV therapy.\]
•3. Were able to ingest and absorb oral medication (in the judgement of the investigator and based on lack of significant gastrointestinal \[GI\] events/medical history).
•4. If male of reproductive potential, were willing to use an acceptable contraceptive method(s) during sexual intercourse with a female partner of reproductive potential throughout the duration of this participation in the study and for at least 6 months after his last dose of BCV.
•5. If female of reproductive potential, i.e., not premenarche, postmenopausal, surgically sterile, or had documented ovarian failure, were willing to use 2 acceptable contraceptive methods, 1 of which must have been a barrier method, during sexual intercourse with a nonsterile male partner, throughout the duration of her participation in the study and for at least 6 months after her last dose of BCV.
•6. Were willing and able to understand and provide written informed consent to participate in the study. \[Note: If the subject was under 18 years of age or was otherwise unable to legally give his or her informed consent to participate in the study, then written informed consent to participate had to be obtained from the parent(s) or legal guardian(s) of the subject or other legal personal representative(s), as applicable. In addition, in the case of minor subjects, the written assent of the subject to participate in the study was obtained where required by applicable institutional policy on the consenting of minor study participants.\]
•7. The subject and his or her caregivers (as applicable) were willing and able to participate in all required study activities for the entire duration of the study (i.e., through completion of Week 36).

Exclusion Criteria

•1. If a female of reproductive potential, the subject was pregnant, planning to become pregnant during the study or within 6 months after their anticipated last BCV dose, or was nursing a child.
•2. Had hypersensitivity (not including renal dysfunction or eye disorder) to cidofovir (CDV) or to BCV or its formulation excipients.
•3. Had received treatment with another investigational drug within 14 days prior to Day 1 unless prior approval was received from the Chimerix medical monitor (or designee).
•4. Were participating in another interventional clinical trial unless prior approval was received from the Chimerix medical monitor (or designee).
•5. Had previously received an anti-AdV vaccine or a cell-based anti-AdV therapy.
•6. Were receiving intravenous (IV) CDV, leflunomide, vidarabine, systemic ribavirin, or another investigational anti-AdV drug at Day 1. \[Note: Subjects who were receiving treatment with IV CDV prior to enrollment had to discontinue IV CDV and wait until a minimum of 48 hours had elapsed from last IV CDV administration before initiating BCV therapy. All other drugs had to be discontinued prior to Day 1.\]
•7. Were receiving digoxin or ketoconazole (other than topical formulations) at Day 1 or were anticipated to need treatment with either drug during the treatment phase of the study.
•8. Were infected with HIV, hepatitis B virus (HBV), and/or hepatitis C virus (HCV), had evidence of active viral replication within 6 months prior to screening, as demonstrated by detectable HIV or HCV RNA, or had detectable HBV DNA in blood, plasma or serum.
•9. Had end-stage renal disease, i.e., an estimated glomerular filtration rate \<15 mL/min, unless receiving renal replacement therapy.
•10. Had a serum alanine aminotransferase or aspartate aminotransferase concentration \>5 x the upper limit of normal (ULN), or a serum total bilirubin concentration \>2 x the ULN and a serum direct (conjugated) bilirubin concentration \>1.5 x the ULN, as reported by the central safety laboratory, unless, in the judgment of the investigator, the abnormality(ies) was/were related to the subject's AdV infection/disease.
+3 more criteria

Locations (33)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Stanford Children's Hospital

Palo Alto, California, United States

Stanford University

Stanford, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Health System

Washington D.C., District of Columbia, United States

Children's Healthcare of Atlanta, Aflac Cancer and Blood Center

Atlanta, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Children's Hospital

New Orleans, Louisiana, United States

Key Dates

Start Date

March 1, 2014

Primary Completion Date

June 1, 2016

Completion Date

August 1, 2016

Last Updated

August 13, 2021

Enrollment

201

ACTUAL participants

Conditions

Adenovirus Infection

Interventions

Brincidofovir

DRUG

A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®

NCT02007356

Adenovirus InfectionEBV+3 more

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COMPLETEDPHASE2/PHASE3

Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

NCT04693637

Adenovirus InfectionBK Virus Infection+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection

Inclusion Criteria

Exclusion Criteria

A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®

Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections