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.
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