Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: REGN7508, REGN9933, Placebo.
- Who it may be relevant to
- Registry conditions: Venous Thromboembolism (VTE). Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Master Protocol for a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, for Prophylaxis of Venous Thromboembolism in Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK)
Overview
This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have a tube placed in a vein to receive treatment (called Peripherally Inserted Central Catheter \[PICC\]). Patients with PICCs have a higher risk of getting blood clots which can block the veins (this is called Venous Thromboembolism \[VTE\]) and lead to serious health problems or be life threatening. The aim of the study is to see how well REGN7508 and REGN9933 prevent blood clots compared to placebo after PICC placement and to see if these medications cause certain types of bleeding. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) * If the study drugs affect the ability of the blood to clot normally
Interventions
- Drug REGN7508
Administered per the protocol - Drug REGN9933
Administered per the protocol - Drug Placebo
Administered per the protocol
Primary outcome measures
- Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE] [Time frame: Approximately 6 months]
- Time-to-first event of centrally adjudicated International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding [Time frame: Approximately 6 months]
Secondary outcome measures (12)
- Time-to-first event of centrally adjudicated symptomatic VTE [symptomatic Deep Vein Thrombosis (DVT) or symptomatic non-fatal Pulmonary Embolism (PE) or VTE-related death] [Time frame: Approximately 6 months]
- Time-to-first event of symptomatic DVT [Time frame: Approximately 6 months]
- Time-to-first event of symptomatic non-fatal PE [Time frame: Approximately 6 months]
- Time-to-first event of VTE-related death [Time frame: Approximately 6 months]
- Time-to-first event of incidental VTE [Time frame: Approximately 6 months]
- Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT [Time frame: Approximately 6 months]
- Time-to-first event of incidental PE (in a segmental or larger pulmonary artery) [Time frame: Approximately 6 months]
- Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound) [Time frame: Approximately 6 months]
- Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to approximately 9 months]
- Severity of TEAEs [Time frame: Up to approximately 9 months]
- Concentrations of REGN7508 [Time frame: Up to approximately 9 months]
- Concentrations of REGN9933 [Time frame: Up to approximately 9 months]
Eligibility criteria
Inclusion criteria
- Is undergoing PICC placement for Intravenous (IV) administration of clinically indicated medications, including chemotherapy, antibiotics, TPN, and/or other indications as described in the protocol
- Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or equivalent functional status as described in the protocol
- Has International Normalization Ratio (INR) and aPTT values no more than 25% above the upper limit as described in the protocol
- Weighs at least 40 kg during the screening period
Exclusion criteria
- Has a history of prior venous thrombosis in the arm and/or ipsilateral thoracic central veins in which the PICC is to be placed
- Has acute leukemia, myelodysplastic syndrome, or primary and secondary myelofibrosis
- Has unresected luminal gastrointestinal (GI) (including esophageal) or unresected genitourinary (GU) malignancy
- Has current or history of known brain tumors or brain metastases
- Has any major cardiovascular event within approximately the past 30 days prior to study administration
- Pre-existing central venous catheter or indwelling spinal or epidural catheter during the screening period
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07697599 · R7508-DVT-25103 · 2026-525288-42-00