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

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ClinicalTrials.gov Identifier: NCT03193502
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : October 13, 2017
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Portal Vein thrombosis
rivaroxaban
Drug: rivaroxaban
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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03193502


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

Locations
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
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

Responsible Party: Sherief Abd-Elsalam, Consultant, Tanta University
ClinicalTrials.gov Identifier: NCT03193502     History of Changes
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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Embolism and Thrombosis
Thrombosis
Venous Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants