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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
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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
Study Design
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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

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


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


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

Inclusion Criteria:

  • Acute PVT

Exclusion Criteria:

  • Malignant PVT
  • Bleeding disorders
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03193502


Contacts
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Contact: Sherief Abd-Elsalam, consultant 00201095159522 Sheriefabdelsalam@yahoo.com

Locations
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Egypt
Tropical medicine dept.-Tanta university hospital Recruiting
Cairo, Egypt
Contact: Sherief Abd-Elsalam    00201095159522    Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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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
More Information
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Responsible Party: Sherief Abd-Elsalam, Consultant, Tanta University
ClinicalTrials.gov 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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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants