Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)

NCT07697599 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: R7508-DVT-251032026-525288-42-00
• Study Type: interventional
• Target: 1,908
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Venous Thromboembolism (VTE)

Keywords

Peripherally Inserted Central Catheter (PICC); Blood clots

Outcome Measures

Primary Outcomes (2)

• Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]

  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

  Approximately 6 months

Secondary Outcomes (18)

• 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]

  Approximately 6 months

• Time-to-first event of symptomatic DVT

  Approximately 6 months

• Time-to-first event of symptomatic non-fatal PE

  Approximately 6 months

• Time-to-first event of VTE-related death

  Approximately 6 months

• Time-to-first event of incidental VTE

  Approximately 6 months

Study Arms (3)

REGN7508

EXPERIMENTAL

Drug: REGN7508

REGN9933

EXPERIMENTAL

Drug: REGN9933

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

REGN7508 DRUG

Administered per the protocol

Also known as: cenvacibart

REGN7508

REGN9933 DRUG

Administered per the protocol

Also known as: amrecibart

REGN9933

Placebo DRUG

Administered per the protocol

Placebo

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Venous Thromboembolism; Thrombosis

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): June 25, 2029
• Study Completion (Estimated): September 21, 2029
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf