Preventing blood clots in adults with a PICC line using new drugs
A Master Protocol for a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of REGN9933 and REGN7508, Monoclonal Antibodies Against Factor XI for Prevention of Venous Thromboembolism in Patients With a Peripherally Inserted Central Catheter (ROXI-CATH)
This study is testing two new drugs to see if they can help prevent blood clots in adults who have a PICC line.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 195 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Locations | 13 sites (Boston, Massachusetts and 12 other locations) |
| Trial ID | NCT06299111 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of two experimental drugs, REGN9933 and REGN7508, in preventing venous thromboembolism (VTE) in adults who have a peripherally inserted central catheter (PICC). Participants will receive either one of the study drugs or a placebo, and the study will monitor various outcomes including side effects, drug levels in the blood, and the body's immune response to the drugs. The goal is to determine how well these drugs can prevent blood clots associated with PICC placement.
Who should consider this trial
Good fit: Ideal candidates are adults who require a PICC line for at least 14 days and meet specific health criteria.
Not a fit: Patients with a history of venous thrombosis in the arm where the PICC will be placed or those with complications from PICC placement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of blood clots in patients with PICC lines, improving patient safety and outcomes.
How similar studies have performed: Other studies have explored similar approaches to preventing VTE, but the specific combination of these drugs is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. PICC 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 ≥50 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 or prophylactic 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) Note: Other protocol defined inclusion/exclusion criteria apply
Where this trial is running
Boston, Massachusetts and 12 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Memorial Sloan Kettering — New York, New York, United States (Recruiting)
- Sveta Sofia Hospital — Sofia, Bulgaria (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Lakeridge Health — Oshawa, Ontario, Canada (Recruiting)
- Soroka University Medical Center — Beer-Sheba, HaDarom, Israel (Recruiting)
- Shaare Zedek Medical Center — Jerusalem, Yerushalayim, Israel (Recruiting)
- Hadassah University Medical Center — Jerusalem, Israel (Recruiting)
- Lanadio Medical Center — Netanya, Israel (Recruiting)
- Rabin Medical Center — Petah Tikva, Israel (Recruiting)
- Sheba Medical Center — Ramat Gan, Israel (Recruiting)
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
- Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca — Cluj-Napoca, Romania (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.