BridgeMD
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)
EU CTIS ID: 2023-508603-21-00
What this study is testing
1. Evaluate the efficacy of REGN9933 and REGN7508 individually, each compared to placebo, for prevention of venous thromboembolism (VTE) after peripherally inserted central catheter (PICC) placement. 2. Assess the overall safety and tolerability of REGN9933 and REGN7508 individually.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- PICC is clinically indicated for at least 14 days and is anticipated to remain in place for at least 14 days
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol
- Body weight ≥45 kg and ≤130 kg during the screening period
- 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
- Platelet count ≥100 x 10^9/L during the screening period as described in the protocol
- Other protocol defined inclusion criteria apply.
You likely can't join if
- 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
- History of prior venous thrombosis in the arm in which the PICC is to be placed
- 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.
- History of known thromboembolic disease or thrombophilia.
- Participants requiring therapeutic anticoagulation and/or antiplatelet therapy as described in the protocol.
- Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol
See the full eligibility criteria
- PICC is clinically indicated for at least 14 days and is anticipated to remain in place for at least 14 days
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol
- Body weight ≥45 kg and ≤130 kg during the screening period
- 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
- Platelet count ≥100 x 10^9/L during the screening period as described in the protocol
- Other protocol defined inclusion criteria apply.
- 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
- History of prior venous thrombosis in the arm in which the PICC is to be placed
- 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.
- History of known thromboembolic disease or thrombophilia.
- Participants requiring therapeutic anticoagulation and/or antiplatelet therapy as described in the protocol.
- Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol
- 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.
- Other protocol defined exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United Kingdom
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United Kingdom; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.