A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)
NCT ID: NCT06299111
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
195 participants
INTERVENTIONAL
2024-09-20
2026-06-08
Brief Summary
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The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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REGN9933
Randomized 1:1:1
REGN9933
Intravenous (IV) single dose administered
REGN7508
Randomized 1:1:1
REGN7508
IV single dose administered
Placebo
Randomized 1:1:1
Placebo
IV single dose administered
Interventions
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REGN9933
Intravenous (IV) single dose administered
REGN7508
IV single dose administered
Placebo
IV single dose administered
Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol
3. Body weight ≥45 kg and ≤130 kg during the screening period
4. International normalized ratio (INR) and aPTT values at or below the upper limit of normal as defined by the local lab during the screening period
5. Platelet count ≥100 x 10\^9/L during the screening period as described in the protocol
Exclusion Criteria
2. History of prior venous thrombosis in the arm in which the PICC is to be placed
3. Peripheral catheter(s) in the same arm in which the PICC is to be placed or expected need for peripheral catheter(s) placement in the same arm the PICC is to be placed as described in the protocol
4. History of known thromboembolic disease or thrombophilia
5. Participants requiring therapeutic anticoagulation and/or antiplatelet therapy as described in the protocol
6. Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol
7. Any history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, traumatic spinal or epidural anesthesia, or history of bleeding diathesis (such as but not limited to Hemophilia A or B, von Willebrand's disease, fibrinogen deficiency, and other inherited or acquired bleeding disorders) as described in the protocol
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Mount Sinai Medical Center
New York, New York, United States
Memorial Sloan Kettering
New York, New York, United States
Sveta Sofia Hospital
Sofia, , Bulgaria
Juravinski Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Soroka University Medical Center
Beersheba, Southern District, Israel
Hadassah University Medical Center
Jerusalem, , Israel
Lanadio Medical Center
Netanya, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Arensia Research Clinic
Bucharest, , Romania
Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca
Cluj-Napoca, , Romania
University hospital Southampton
Southampton, Hampshire, United Kingdom
Cardiff and Vale University Health Board - University Hospital Wales
Cardiff, Wales, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Related Links
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ROXI-CATH
Other Identifiers
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2023-508603-21-00
Identifier Type: CTIS
Identifier Source: secondary_id
R9933-DVT-2308
Identifier Type: -
Identifier Source: org_study_id