Phase
Condition
Venous Thromboembolism
Venous Thrombosis
Blood Clots
Treatment
Placebo
REGN7508
REGN9933
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
PICC is anticipated to remain in place for at least 14 days
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalentfunctional status as described in the protocol
Body weight ≥50 kg and ≤130 kg during the screening period
International normalized ratio (INR) and aPTT values at or below the upper limit ofnormal as defined by the local lab during the screening period
Platelet count ≥100 x 10^9/L during the screening period as described in theprotocol
Exclusion
Key Exclusion Criteria:
Unsuccessful PICC placement or any other complication associated with this procedurethat in the opinion of the study investigator may present any safety concerns to theparticipant
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 expectedneed for peripheral catheter(s) placement in the same arm the PICC is to be placedas described in the protocol
History of known thromboembolic disease or thrombophilia
Participants requiring therapeutic or prophylactic anticoagulation and/orantiplatelet therapy as described in the protocol
Expected to receive cancer therapy or other medication associated with a priorepisode of Grade 4 thrombocytopenia as described in the protocol
Any history of intracranial or intraocular bleeding, excessive operative orpost-operative bleeding, traumatic spinal or epidural anesthesia, or history ofbleeding diathesis (such as but not limited to Hemophilia A or B, von Willebrand'sdisease, fibrinogen deficiency, and other inherited or acquired bleeding disorders)
Note: Other protocol defined inclusion/exclusion criteria apply
Study Design
Connect with a study center
Sveta Sofia Hospital
Sofia, 1000
BulgariaActive - Recruiting
Lakeridge Health
Oshawa, Ontario L1G 2B9
CanadaActive - Recruiting
Soroka University Medical Center
Beer-Sheba, HaDarom 84101
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem, Yerushalayim 9103102
IsraelActive - Recruiting
Hadassah University Medical Center
Jerusalem, 91120
IsraelActive - Recruiting
Lanadio Medical Center
Netanya, 4244916
IsraelActive - Recruiting
Rabin Medical Center
Petah Tikva, 49100
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan, 5265601
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
IsraelActive - Recruiting
Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca
Cluj-Napoca, 400006
RomaniaActive - Recruiting
Memorial Sloan Kettering
New York, New York 10065
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.