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

Phase 3

Completed

Conditions: Adenovirus Infection

Interventions: Drug: Brincidofovir

Registration Number: NCT02087306

Lead Sponsor: Chimerix

Brief 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 201

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brincidofovir	Brincidofovir	Subjects who weighed \<50 kg received 2 mg/kg (not to exceed 100 mg) BCV twice weekly administered orally as the appropriate volume of 10-mg/mL liquid suspension. Subjects who weighed ≥50 kg received 100 mg BCV twice weekly administered orally as one 100 mg tablet (or the appropriate volume of 10-mg/mL liquid suspension if unable to swallow solid medicine).

Primary Outcome Measures

Name	Time	Method
Number of Participants With All-Cause Mortality	60 days	The primary efficacy endpoint was the evaluation of the effect of brincidofovir (BCV) on all-cause mortality when used for the treatment of disseminated adenovirus (AdV) disease in all hematopoietic cell transplant (HCT) recipients. The primary endpoint associated with this objective was all-cause mortality through Day 60.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Reduction in Adenovirus Viremia	Assessed 13 weeks (through 7 days post-last BCV dose); during treatment up to 12 weeks reported	A secondary endpoint was the evaluation of virologic response (plasma adenovirus \[AdV\] DNA viremia) to brincidofovir treatment. Blood (plasma) was collected at screening, before dosing on Day 1 (to establish baseline), and at each subsequent assessment during the treatment and post-treatment phases for the analysis of AdV DNA viremia. All samples collected for analysis of AdV were analyzed by the designated central virology laboratory using proprietary real-time quantitative polymerase chain reaction (qPCR) assays. AdV in plasma were analyzed using the 7500 AdV qPCR Test, where the standardized assay plasma ranged from 190 copies/mL to 1 X 10\^10 copies/mL. A "positive or detectable" result referred to the measurement of AdV DNA at concentrations ≥190 copies/mL, a result below the lower limit of detection (LLOQ) (i.e., not detected) was imputed as 1 copy/mL, and a result below the lower limit of quantitation but detected will be imputed at 1 unit less than LLOQ (e.g., 189 copies/mL).
Mean Minimum On-treatment Value log10 Copies/mL Change From Baseline	Baseline to 12 weeks	A secondary endpoint was the evaluation of virologic response (plasma adenovirus \[AdV\] DNA viremia) to brincidofovir treatment. Blood (plasma) was collected at screening, before dosing on Day 1 (to establish baseline), and at each subsequent assessment during the treatment and post-treatment phases for the analysis of AdV DNA viremia. All samples collected for analysis of AdV were analyzed by the designated central virology laboratory using proprietary real-time quantitative polymerase chain reaction (qPCR) assays. AdV in plasma were analyzed using the 7500 AdV qPCR Test, where the standardized assay plasma ranged from 190 copies/mL to 1 X 10\^10 copies/mL. A "positive or detectable" result referred to the measurement of AdV DNA at concentrations ≥190 copies/mL, a result below the lower limit of detection (LLOQ) (i.e., not detected) was imputed as 1 copy/mL, and a result below the lower limit of quantitation but detected will be imputed at 1 unit less than LLOQ (e.g., 189 copies/mL).

Trial Locations

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, 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
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Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States