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This Phase 3, multi-center, global, randomized, open-label study will assess efficacy of IV BCV, compared to IV CDV, in subjects after allogeneic hematopoietic cell transplantation (allo-HCT) with AdV viremia.

Who can Participate

Patients must be post-allo HCT within last 180 days, aged 2 months and older at time of signing informed consent form and (if applicable) have a guardian willing and able to understand and provide written informed consent to participate in the study; have adenoviremia and in the investigators judgement, the subjects clinical condition justifies treatment with IV BCV or IV CDV for AdV infection; and must be willing to use acceptable method(s) of contraception during the study and for at least 6 months after the last dose of IV BCV or at least 6 months after the last dose of IV CDV. Written informed consent 1. Male and female, post-allo HCT within last 180 days, aged 2 months and older at time of signing informed consent form. 2. Subject/Guardian willing and able to understand and provide written informed consent to participate in the study. Adenoviral disease 3. In the investigators judgement, the subjects clinical condition justifies treatment with IV BCV or IV CDV for AdV infection. 4. Has adenoviremia, based on any of: - AdV viremia DNA greater than or equal to 10,000 IU/mL, OR - Two consecutive and rising AdV viremia DNA results of greater than or equal to 1,000 IU/mL at screening, OR - AdV viremia DNA of greater than or equal to 1,000 IU/mL, AND 1. Lymphocyte count less than 180/mm^3, OR 2. Received T cell depletion, cord blood, or haploidentical transplant, OR 3. prior alemtuzumab, OR 4. anti-thymocyte globulin (ATG) Reproductive health 5. Men and women of childbearing potential (WOCBP) must be willing to use acceptable method(s) of contraception during the study and for at least 6 months after the last dose of IV BCV or at least 6 months after the last dose of IV CDV. 6. WOCBP must agree to use two (2) acceptable forms of contraception (one of which must be a barrier method) during heterosexual intercourse. Males capable of fathering a child must agree to use acceptable method(s) of contraception during heterosexual intercourse. 7. Subject is non-pregnant, and either not breast feeding or willing to discontinue breast feeding prior to randomization.

Study ID

More information available at ClinicalTrials.gov: NCT07387367