Phase
Condition
Venous Thromboembolism
Venous Thrombosis
Thromboembolism
Treatment
Placebo
REGN9933
REGN7508
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
PICC is clinically indicated for at least 14 days and is anticipated to remain inplace for at least 14 days
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalentfunctional 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 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 anticoagulation and/or antiplatelet therapy asdescribed 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)as described in the protocol
Note: Other protocol defined inclusion/exclusion criteria apply
Study Design
Connect with a study center
SVETA Sofia Hospital
Sofia, 1000
BulgariaSite Not Available
Sveta Sofia Hospital
Sofia 727011, 1000
BulgariaSite Not Available
London Health Sciences Centre
London, Ontario N6A 4L6
CanadaSite Not Available
Lakeridge Health
Oshawa, Ontario L1G 2B9
CanadaSite Not Available
University Health Network
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Juravinski Hospital
Hamilton 5969782, Ontario 6093943 L8V 1C3
CanadaSite Not Available
London Health Sciences Centre
London 6058560, Ontario 6093943 N6A 4L6
CanadaSite Not Available
Lakeridge Health
Oshawa 6094578, Ontario 6093943 L1G 2B9
CanadaSite Not Available
University Health Network
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaSite Not Available
Soroka University Medical Center
Beer-Sheba, HaDarom 84101
IsraelSite Not Available
Shaare Zedek Medical Center
Jerusalem 281184, Jerusalem 293198 9103102
IsraelSite Not Available
Soroka University Medical Center
Beersheba 295530, Southern District 294952 84101
IsraelSite Not Available
Shaare Zedek Medical Center
Jerusalem, Yerushalayim 9103102
IsraelSite Not Available
Hadassah University Medical Center
Jerusalem, 91120
IsraelActive - Recruiting
Hadassah University Medical Center
Jerusalem 281184, 91120
IsraelSite Not Available
Lanadio Medical Center
Netanya, 4244916
IsraelSite Not Available
Lanadio Medical Center
Netanya 294071, 4244916
IsraelSite Not Available
Rabin Medical Center
Petah Tikva, 49100
IsraelSite Not Available
Rabin Medical Center
Petah Tikva 293918, 49100
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, 5265601
IsraelSite Not Available
Sheba Medical Center
Ramat Gan 293788, 5265601
IsraelSite Not Available
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
IsraelSite Not Available
Tel Aviv Sourasky Medical Center
Tel Aviv 293397, 64239
IsraelSite Not Available
Arensia Research Clinic
Bucharest 683506, 011658
RomaniaSite Not Available
ARENSIA Exploratory Medicine Clinic at Country Hospital Cluj-Napoca
Cluj-Napoca, 400006
RomaniaSite Not Available
Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca
Cluj-Napoca 681290, 400006
RomaniaSite Not Available
University hospital Southampton
Southampton 2637487, Hampshire SO16 6YD
United KingdomSite Not Available
Cardiff and Vale University Health Board - University Hospital Wales
Cardiff, Wales Cf14 4Xw
United KingdomSite Not Available
Cardiff and Vale University Health Board - University Hospital Wales
Cardiff 2653822, Wales 2634895 CF14 4XW
United KingdomSite Not Available
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne, NE1 4LP
United KingdomSite Not Available
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne 2641673, NE1 4LP
United KingdomSite Not Available
Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
United StatesSite Not Available
Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United StatesSite Not Available
Sylvester Comprehensive Cancer Center
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202
United StatesSite Not Available
Memorial Sloan Kettering
New York, New York 10065
United StatesActive - Recruiting
Mount Sinai Medical Center
New York, New York 10029
United StatesSite Not Available
Memorial Sloan Kettering
New York 5128581, New York 5128638 10065
United StatesSite Not Available
Mount Sinai Medical Center
New York 5128581, New York 5128638 10029
United StatesSite Not Available

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