NCT03193502

Brief Summary

-Rivaroxaban is factor Xa inhibitor

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

6.2 years

First QC Date

June 17, 2017

Last Update Submit

October 12, 2017

Conditions

Portal Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Number of patients with recanalized portal vein

    recanalization of portal vein

    6 months

Study Arms (1)

Portal Vein thrombosis

EXPERIMENTAL

rivaroxaban

Drug: rivaroxaban

Interventions

rivaroxabanDRUG

rivaroxaban

Also known as: xarelto
Portal Vein thrombosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Acute PVT

You may not qualify if:

  • Malignant PVT
  • Bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical medicine dept.-Tanta university hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Amr Hanafy, Professor

    Hepatology unit - Zagazig University

    PRINCIPAL INVESTIGATOR

  • Mohamed Basha, Consultant

    Radiology Dept - Zagazig University

    STUDY DIRECTOR

  • Sherief Abd-elsalam, consultant

    Hepatology - Gastroenterology - Tanta University

    STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, consultant

CONTACT

00201095159522Sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

June 17, 2017

First Posted

June 20, 2017

Study Start

May 1, 2014

Primary Completion

July 1, 2020

Study Completion

December 1, 2020

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

EG(1)