New antibody drugs aim to stop Catheter-Related clots
NCT ID NCT06299111
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested two experimental drugs, REGN9933 and REGN7508, to see if they can prevent venous thromboembolism (blood clots) in adults who need a PICC line for at least 14 days. The drugs are monoclonal antibodies that target a clotting factor. 195 participants received a single IV dose of one of the drugs or a placebo. Researchers measured how many people developed clots, as well as side effects and bleeding risks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- REGN9933 and REGN7508 (monoclonal antibodies against factor XI)
- What this could lead to
- If successful, these drugs could offer a new way to prevent dangerous blood clots in people with central catheters, potentially reducing the need for standard blood thinners.
- What could go wrong
- This is an early Phase 2 trial with only 195 participants, so results may not apply to everyone. The drugs could cause bleeding or other side effects, and they may not work better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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195 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Mar 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: 1. PICC is clinically indicated for at least 14 days and is anticipated to remain in place for at least 14 days 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 Key Exclusion Criteria: 1. Unsuccessful PICC placement or any other complication associated with this procedure that in the opinion of the study investigator may present any safety concerns to the participant 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 Note: Other protocol defined inclusion/exclusion criteria apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca
Cluj-Napoca, 400006, Romania
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Arensia Research Clinic
Bucharest, 011658, Romania
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Cardiff and Vale University Health Board - University Hospital Wales
Cardiff, Wales, CF14 4XW, United Kingdom
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Hadassah University Medical Center
Jerusalem, 91120, Israel
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Henry Ford Health System
Detroit, Michigan, 48202, United States
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Juravinski Hospital
Hamilton, Ontario, L8V 1C3, Canada
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Lakeridge Health
Oshawa, Ontario, L1G 2B9, Canada
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Lanadio Medical Center
Netanya, 4244916, Israel
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London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
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Memorial Sloan Kettering
New York, New York, 10065, United States
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Mount Sinai Medical Center
New York, New York, 10029, United States
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Rabin Medical Center
Petah Tikva, 49100, Israel
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Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9103102, Israel
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Sheba Medical Center
Ramat Gan, 5265601, Israel
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Soroka University Medical Center
Beersheba, Southern District, 84101, Israel
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Sveta Sofia Hospital
Sofia, 1000, Bulgaria
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Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
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Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
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The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP, United Kingdom
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University Health Network
Toronto, Ontario, M5G 2M9, Canada
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University hospital Southampton
Southampton, Hampshire, SO16 6YD, United Kingdom
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Other studies related to the condition(s) this trial covers.
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