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A Phase 3, Multicenter, Prospective, Randomized, Open-label Efficacy and Safety Study of Intravenous Brincidofovir versus Intravenous Cidofovir for Treatment of Adenovirus Infection in Pediatric and Adult Subjects After Allogeneic Hematopoietic Cell Transplantation (allo HCT)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521903-28-00
Acronym
BCV-PA02
Enrollment
72
Registered
2025-10-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenovirus viremia

Brief summary

Proportion of subjects with AdV virological success

Detailed description

Proportion of subjects with overall success, Proportion of subjects with clinical success, Proportion of subjects with AdV virological success, Correlation of virologic success and clinical response, AdV-free survival, Time to AdV virological success, Rate of AdV recurrence, Length of hospitalization and length of ICU stay, Desirability Of Outcome Ranking (DOOR) Analysis for benefit-risk estimation, All-cause mortality, Adenovirus attributed mortality, as adjudicated by the EAC, Primary malignancy relapse-free survival, Incidence and severity of treatment-emergent adverse events (TEAEs)

Interventions

DRUGBrincidofovir
DRUGCidofovir

Sponsors

Symbio Pharmaceuticals Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of subjects with AdV virological success—

Secondary

MeasureTime frame
Proportion of subjects with overall success, Proportion of subjects with clinical success, Proportion of subjects with AdV virological success, Correlation of virologic success and clinical response, AdV-free survival, Time to AdV virological success, Rate of AdV recurrence, Length of hospitalization and length of ICU stay, Desirability Of Outcome Ranking (DOOR) Analysis for benefit-risk estimation, All-cause mortality, Adenovirus attributed mortality, as adjudicated by the EAC, Primary malignancy relapse-free survival, Incidence and severity of treatment-emergent adverse events (TEAEs)—

Countries

France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026