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Brincidofovir · 6 trials · 6 indications
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.
Clinically significant cytomegalovirus (CMV) infection was defined by either of the following outcomes: 1. Onset of CMV end-organ disease; or 2. Initiation of anti-CMV-specific preemptive therapy based on documented CMV viremia (as measured by the central virology laboratory) and the clinical condition of the subject. CMV viremia (i.e., the measurement of CMV DNA in plasma) was determined by the designated central virology laboratory at all scheduled visits via quantitative polymerase chain reaction (qPCR) testing using the Roche COBAS® AmpliPrep/COBAS® TaqMan® CMV Test.
Proportion of subjects who achieved a confirmed reduction in viral load for the primary dsDNA virus of ≥1 log10 copies/mL from baseline or to an undetectable level. Confirmation required the reduction in viral load (i.e., decrease of ≥ 1 log10 copies/mL from baseline or to undetectable levels) to be maintained at the next assessment for the subject to be considered a success.
The primary objective of this study was to evaluate the safety and efficacy of preemptive treatment with brincidofovir (BCV) versus placebo for the prevention of adenovirus (AdV) disease in recipients of hematopoietic stem cell transplantation (HCT) with asymptomatic AdV viremia. The outcome measure for the primary endpoint was treatment failure, a composite endpoint that consisted of the following: * Progression to probable AdV disease (other positive causes/agents have been ruled out and subject has disease-targeted organ-specific signs or symptoms) or definitive AdV disease (AdV detected in disease-targeted organ/system biopsy via antigen/immunohistochemistry, culture, and/or polymerase chain reaction and has at least 1 disease-targeted organ-specific sign or symptom); or * Increasing AdV viremia (defined as an increase from baseline in AdV viremia by ≥1 log10, confirmed on a second measurement, at least 1 week apart) and requiring discontinuation from blinded therapy.
The primary efficacy endpoint was a binomial outcome of failure to prevent cytomegalovirus (CMV) infection defined as CMV DNAemia \>200 copies/mL obtained at the time of the last treatment with study drug or diagnosis of CMV disease at some point during the treatment phase.
The primary objective of this study was to determine the safety and tolerability of brincidofovir (BCV) in post-transplant patients with BK virus viruria. Safety measures included adverse events, clinical laboratory values, vital signs, and renal and gastrointestinal function.
| Arm | Type | Description |
|---|---|---|
| Brincidofovir | EXPERIMENTAL | 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). |
| Placebo | PLACEBO_COMPARATOR | Matching placebo administered orally twice weekly |
| Name | Type | Description |
|---|---|---|
| Brincidofovir | DRUG | BCV administered twice weekly, dose depending on weight. |
| Placebo | OTHER | - |
Inclusion Criteria Subjects were required to meet all of the following criteria, as applicable, to be eligible to participate in this study. 1. Were male or female, aged 2 months or older. 2. Had either of the following: * Disseminated adenovirus (AdV) disease; or * An underlying immunocompr...
Brincidofovir is an investigational small molecule being developed for infectious disease, specifically for conditions caused by double-stranded DNA viruses, including adenovirus disease, adenovirus infection, cytomegalovirus infection, and viruria. It is currently in Phase 2 clinical development.
Brincidofovir targets double-stranded DNA viruses, which include adenovirus and cytomegalovirus. It is designed to treat or prevent infections caused by these viruses, such as adenovirus disease and viruria.
Brincidofovir is being developed by Jazz Pharmaceuticals plc, a company traded on the stock exchange under the ticker JAZZ.
Brincidofovir is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed, including a Phase 2 study for the prevention of adenovirus disease.
Brincidofovir has completed several clinical trials, including NCT01241344, a Phase 2 study for the prevention of adenovirus disease, and NCT01143181, a Phase 3 study for serious diseases caused by double-stranded DNA viruses. Other completed trials include NCT00793598 and NCT02087306.
Brincidofovir is also known as CMX001. One completed trial, NCT00793598, was titled 'CMX001 in Post-transplant Patients With BK Virus Viruria,' indicating the drug was previously referred to by that name.