Back to resultsEfficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic PVT Compensated Cirrhosis
Primary Purpose
Portal Vein Thrombosis
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
rivaroxaban
Sponsored by
About this trial
This is an interventional treatment trial for Portal Vein Thrombosis
Eligibility Criteria
Inclusion Criteria:
- Acute PVT
Exclusion Criteria:
- Malignant PVT
- Bleeding disorders
Sites / Locations
- Tropical medicine dept.-Tanta university hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Portal Vein thrombosis
Arm Description
rivaroxaban
Outcomes
Primary Outcome Measures
Number of patients with recanalized portal vein
recanalization of portal vein
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03193502
Brief Title
Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic PVT Compensated Cirrhosis
Official Title
Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic Portal Vein Thrombosis in HCV Related Compensated Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2014 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
-Rivaroxaban is factor Xa inhibitor
Detailed Description
PVT is a common complication of liver cirrhosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Vein Thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Portal Vein thrombosis
Arm Type
Experimental
Arm Description
rivaroxaban
Intervention Type
Drug
Intervention Name(s)
rivaroxaban
Other Intervention Name(s)
xarelto
Intervention Description
rivaroxaban
Primary Outcome Measure Information:
Title
Number of patients with recanalized portal vein
Description
recanalization of portal vein
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute PVT
Exclusion Criteria:
Malignant PVT
Bleeding disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, consultant
Phone
00201095159522
Email
Sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Hanafy, Professor
Organizational Affiliation
Hepatology unit - Zagazig University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Basha, Consultant
Organizational Affiliation
Radiology Dept - Zagazig University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sherief Abd-elsalam, consultant
Organizational Affiliation
Hepatology - Gastroenterology - Tanta University
Official's Role
Study Chair
Facility Information:
Facility Name
Tropical medicine dept.-Tanta university hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam
Phone
00201095159522
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic PVT Compensated Cirrhosis
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