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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

Tracking Information
First Submitted Date  ICMJE June 17, 2017
First Posted Date  ICMJE June 20, 2017
Last Update Posted Date October 13, 2017
Actual Study Start Date  ICMJE May 1, 2014
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2017)
Number of patients with recanalized portal vein [ Time Frame: 6 months ]
recanalization of portal vein
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic PVT Compensated Cirrhosis
Official Title  ICMJE Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic Portal Vein Thrombosis in HCV Related Compensated Cirrhosis
Brief Summary -Rivaroxaban is factor Xa inhibitor
Detailed Description PVT is a common complication of liver cirrhosis
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Portal Vein Thrombosis
Intervention  ICMJE Drug: rivaroxaban
rivaroxaban
Other Name: xarelto
Study Arms  ICMJE Experimental: Portal Vein thrombosis
rivaroxaban
Intervention: Drug: rivaroxaban
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 17, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acute PVT

Exclusion Criteria:

  • Malignant PVT
  • Bleeding disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03193502
Other Study ID Numbers  ICMJE Amr Hanafy
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sherief Abd-Elsalam, Tanta University
Study Sponsor  ICMJE Sherief Abd-Elsalam
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Tanta University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP