A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT

Recruiting Phase 3 Interventional Study
Adenovirus Infections
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 Months and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
180 (estimated)
Sponsor
SymBio Pharmaceuticals · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 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. 3. In the investigator's judgement, the …
Contacts

Rochelle Maher

+1-917-656-6951

MedInfo@symbiopharma.com

CONTACT