The Effect of Rifaximin on Portal Vein Thrombosis (ERPVT)

August 12, 2018 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

The Effect of Rifaximin on Portal Vein Thrombosis in Cirrhotic Patients

The aim of this study is to evaluate the efficacy of rifaximin in the treatment of portal vein thrombosis in cirrhotic patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Portal vein thrombosis is not an uncommon complication in cirrhotic portal hypertension, which lead to a poor prognosis in endoscopic management of variceal bleeding. Evidence indicated that enoxaparin prevented PVT and liver decompensation via decreased rates of bacterial infections and lowered the potent inflammatory mediators such as interleukin-6. Rifaximin is a broad-spectrum antibiotic that exerts endotoxin-lowering and anti-inflammatory effects.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • 180 Fenglin Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 y.o. ≤age≤75 y.o
  • Cirrhotic patients had CTA confirmed portal vein trombosis
  • D-dimer no more than five times the normal upper limit

Exclusion Criteria:

  • age <18 y.o. or age > 75 y.o.
  • had portal cavernoma
  • received anticoagulation treatment in the past 6 months
  • splenectomy
  • Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
  • Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics.
  • Acute variceal bleeding within 5 days.
  • Use of other antibiotics in the past 2 weeks
  • Acute portal vein thrombosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rifaximin treatment group
Rifaximin 400mg bid for 8 weeks
Drug: Rifaximin
400mg bid for 8 weeks
Other Names:
  • XIFAXAN
No Intervention: The control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of portal vein thrombosis
Time Frame: 8 weeks
The changes of portal vein thrombosis in 8 weeks (include main portal vein, left and/or right portal vein, superior mesenteric vein, et al)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of portal vein thrombosis
Time Frame: 6 months
The changes of portal vein thrombosis in 8 weeks (include main portal vein, left and/or right portal vein, superior mesenteric vein, et al)
6 months
All clinical events
Time Frame: 8 weeks
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death
8 weeks
All clinical events
Time Frame: 6 months
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 3, 2018

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

August 12, 2018

First Submitted That Met QC Criteria

August 12, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 12, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSY-RFXM-PVT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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