ClinicaliQ Trial Snapshot
- A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT — Recruiting • Phase III • Infectious Disease • NCT07387367.
- What is being tested: This Phase 3 trial compares two intravenous antiviral treatments—brincidofovir (BCV) and cidofovir (CDV)—for managing adenovirus (AdV) viremia in allogeneic hematopoietic cell transplant (allo-HCT) recipients, using a virologic response-driven approach to determine treatment duration.
- Patient eligibility overview: The trial enrolls adult and pediatric patients who have undergone allo-HCT and developed confirmed AdV viremia, representing a high-risk immunocompromised population vulnerable to serious viral complications.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
This randomized, open-label, parallel group, two-arm, multi-center assessment will compare IV BCV with IV CDV in adult and pediatric allogeneic HCT recipients with AdV viremia. A virologic response-driven approach to duration of treatment will be evaluated, in which randomized subjects are treated with either BCV or CDV until AdV viremia is confirmed as undetectable or until a maximum of 12 weeks of therapy, whichever occurs first. All subjects will be followed for a total of 24 weeks post-randomization, regardless of treatment assignment. Subjects will be assessed on a weekly basis…
Eligibility Snapshot
- : 1. Male and female, post-allo HCT within last 180 days, aged 2 months and older at time of signing informed consent form.
- Subject/Guardian willing and able to understand and provide written informed consent to participate in the study. 3. In the investigator's judgement, the subject's clinical condition justifies treatment with IV BCV or IV CDV for AdV infection. 4. Has adenoviremia, based on any of: * AdV viremia DNA ≥10,000 IU/mL, OR * Two consecutive and rising AdV viremia DNA results of ≥1,000 IU/mL at screening, OR * AdV viremia DNA of ≥1,000 IU/mL, AND 1. Lymphocyte count
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.