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A Master Protocol for a Phase 2 Randomized, Double-blind, Placebo-controlled Study of REGN9933 and REGN7508, Monoclonal Antibodies against Factor XI for Prevention of Venous Thromboembolism in Patients with a Peripherally Inserted Central Catheter (ROXI-CATH).

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508603-21-00
Acronym
R9933-DVT-2308
Enrollment
93
Registered
2024-08-12
Start date
2024-09-20
Completion date
Unknown
Last updated
2026-01-26

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

Conditions

Venous Thromboembolism

Brief summary

Incidence of confirmed VTE per central reading center (CRC) review, Incidence and severity of treatment-emergent adverse events (TEAE)

Detailed description

Incidence of confirmed PICC-associated venous thrombosis per CRC review, Incidence of major bleeding and clinically relevant non-major (CRNM) bleeding, Concentrations of REGN9933, Concentrations of REGN7508, Change in activated partial thromboplastin time (aPTT) and in prothrombin time (PT), Incidence and magnitude of anti-drug antibodies (ADA) to REGN9933 over time, Incidence and magnitude of ADA to REGN7508 over time

Interventions

DRUGPlacebo matching REGN9933
DRUGPlacebo matching REGN7508

Sponsors

Regeneron Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of confirmed VTE per central reading center (CRC) review, Incidence and severity of treatment-emergent adverse events (TEAE)

Secondary

MeasureTime frame
Incidence of confirmed PICC-associated venous thrombosis per CRC review, Incidence of major bleeding and clinically relevant non-major (CRNM) bleeding, Concentrations of REGN9933, Concentrations of REGN7508, Change in activated partial thromboplastin time (aPTT) and in prothrombin time (PT), Incidence and magnitude of anti-drug antibodies (ADA) to REGN9933 over time, Incidence and magnitude of ADA to REGN7508 over time

Countries

Bulgaria, Romania, Spain

Outcome results

None listed

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