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Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic PVT Compensated Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03193502
Recruitment Status : Unknown
Verified October 2017 by Sherief Abd-Elsalam, Tanta University.
Recruitment status was:  Recruiting
First Posted : June 20, 2017
Last Update Posted : October 13, 2017
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Brief Summary:
-Rivaroxaban is factor Xa inhibitor

Condition or disease Intervention/treatment Phase
Portal Vein Thrombosis Drug: rivaroxaban Phase 3

Detailed Description:
PVT is a common complication of liver cirrhosis

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic Portal Vein Thrombosis in HCV Related Compensated Cirrhosis
Actual Study Start Date : May 1, 2014
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: Portal Vein thrombosis
Drug: rivaroxaban
Other Name: xarelto

Primary Outcome Measures :
  1. Number of patients with recanalized portal vein [ Time Frame: 6 months ]
    recanalization of portal vein

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute PVT

Exclusion Criteria:

  • Malignant PVT
  • Bleeding disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03193502

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Contact: Sherief Abd-Elsalam, consultant 00201095159522

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Tropical medicine dept.-Tanta university hospital Recruiting
Cairo, Egypt
Contact: Sherief Abd-Elsalam    00201095159522   
Sponsors and Collaborators
Sherief Abd-Elsalam
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Principal Investigator: Amr Hanafy, Professor Hepatology unit - Zagazig University
Study Director: Mohamed Basha, Consultant Radiology Dept - Zagazig University
Study Chair: Sherief Abd-elsalam, consultant Hepatology - Gastroenterology - Tanta University
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Responsible Party: Sherief Abd-Elsalam, Consultant, Tanta University Identifier: NCT03193502    
Other Study ID Numbers: Amr Hanafy
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action