Study on How REGN9933 and REGN7508 Help Prevent Blood Clots in Adults with a Peripherally Inserted Central Catheter (PICC)

What is this study about?

This clinical trial is focused on studying the prevention of venous thromboembolism, which is a condition where blood clots form in the veins. The study involves two investigational treatments, REGN9933 and REGN7508, which are types of monoclonal antibodies. Monoclonal antibodies are special proteins designed to target specific substances in the body. In this case, they target a protein involved in blood clotting called Factor XI. The trial will compare the effects of these treatments to a placebo in patients who have a peripherally inserted central catheter (PICC), a type of long-term intravenous line.

The purpose of the study is to evaluate how well REGN9933 and REGN7508 work in preventing blood clots and to assess their safety. Participants in the study will receive either REGN9933, REGN7508, or a placebo. The treatments are given as a powder mixed into a solution and administered through an intravenous infusion, which means they are delivered directly into the bloodstream. The study will monitor participants for any side effects and measure the concentration of the drugs in the body over time.

Throughout the study, the incidence of blood clots and any bleeding events will be closely observed. The study aims to provide valuable information on the effectiveness and safety of these treatments in preventing blood clots in patients with a PICC. This research could potentially lead to new ways to prevent venous thromboembolism in patients who require long-term intravenous access.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as having a peripherally inserted central catheter (PICC) expected to remain for at least 14 days, a body weight between 50 kg and 130 kg, and normal blood test results for clotting and platelet count.

2 randomization and treatment assignment

Participants are randomly assigned to receive either the study medication or a placebo. The study medications are REGN9933 and REGN7508, both administered as a powder for solution for infusion through intravenous use.

3 treatment administration

The assigned treatment is administered intravenously. The frequency and duration of administration are determined by the study protocol, focusing on preventing blood clots in patients with a PICC.

4 monitoring and follow-up

Participants are monitored for the incidence of confirmed venous thromboembolism (VTE) and any treatment-emergent adverse events. Regular assessments include checking for PICC-associated thrombosis, major bleeding, and changes in blood clotting times.

Blood samples may be taken to measure the concentration of the study medications and to check for any antibodies that might develop against them.

5 completion of the study

The study is expected to conclude by June 2026. Participants will have a final assessment to evaluate the overall safety and effectiveness of the treatment they received.

Who Can Join the Study?

The patient must have a PICC (a type of long, thin tube inserted into a vein) that is expected to stay in place for at least 14 days.
The patient should have an ECOG Performance Status of 2 or less. This is a scale that measures how well a patient can perform daily activities.
The patient’s body weight should be between 50 kg (about 110 pounds) and 130 kg (about 286 pounds) during the screening period.
The patient’s INR (a blood test that measures how long it takes for blood to clot) and aPTT (another blood clotting test) should be at or below the normal range as defined by the local lab during the screening period.
The patient’s platelet count (a measure of the number of platelets in the blood, which help with clotting) should be at least 100 x 10^9/L during the screening period.
Other criteria defined in the study protocol may also apply.
The study is open to both male and female participants.
The study is not specifically targeting vulnerable populations.

Who Cannot Join the Study?

Patients who have a history of venous thromboembolism (a condition where blood clots form in the veins) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.
Patients who are currently participating in another clinical trial cannot participate in this study.
Patients who have had a peripherally inserted central catheter (PICC) (a long, thin tube inserted into a vein in the arm) placed recently cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain
Spitalul Clinic Judetean De Urgenta Cluj	Cluj Napoca	Romania

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Multispecialty hospital for active treatment Sveta Sofia EOOD	Sofia	Bulgaria
Ajlxaji Cvphtyt Sqitqm	Bucharest	Romania

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	31.08.2024
Romania	Not recruiting	31.08.2024
Spain	Not recruiting	31.08.2024

Trial locations

Investigated drugs:

REGN9933 is a monoclonal antibody being studied for its ability to prevent venous thromboembolism (VTE) in patients who have had a peripherally inserted central catheter (PICC) placed. This medication works by targeting a specific factor in the blood that is involved in clot formation, potentially reducing the risk of developing dangerous blood clots.

REGN7508 is another monoclonal antibody included in the study, also aimed at preventing venous thromboembolism (VTE) in patients with a peripherally inserted central catheter (PICC). Similar to REGN9933, this medication targets a factor in the blood that contributes to clotting, helping to prevent the formation of harmful blood clots.

Venous Thromboembolism – This condition involves the formation of blood clots in the veins, which can lead to complications if the clots travel to other parts of the body. It typically begins with a clot forming in a deep vein, often in the legs, known as deep vein thrombosis (DVT). If a part of this clot breaks off, it can travel to the lungs, causing a pulmonary embolism (PE), which can obstruct blood flow. Symptoms may include swelling, pain, and redness in the affected area, as well as shortness of breath and chest pain if a PE occurs. The condition can develop after certain medical procedures, such as the placement of a peripherally inserted central catheter (PICC). Regular monitoring and preventive measures are important to manage the risk of clot formation.

Trial ID:

2023-508603-21-00

Protocol code:

R9933-DVT-2308

NCT ID:

NCT06299111

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on How REGN9933 and REGN7508 Help Prevent Blood Clots in Adults with a Peripherally Inserted Central Catheter (PICC)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?