NCT02508623

Brief Summary

The purpose of this study is to assess whether the add of Rifaximin in patients with liver cirrhosis and esophageal varices treated with a standard therapy with beta blockers, leads to a significant reduction of portal hypertension.

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
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2015

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

July 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

July 21, 2015

Last Update Submit

July 27, 2015

Conditions

Liver CirrhosisPortal Hypertension

Keywords

Portal hypertensionliver cirrhosisRifaximin

Outcome Measures

Primary Outcomes (1)

  • Change of Hepatic Venous Pressure Gradient

    At Time 0 and after 60 days all patients will underwent hepatic vein catheterization to obtain the Hepatic Venous Pressure Gradient. Treatment response is defined as a decrease from baseline in the hepatic venous pressure gradient of at least 20% or less than 12 mmHg

    Time 0 and after 60 days

Secondary Outcomes (3)

  • Modification of fecal bacteria

    Time 0 and after 60 days

  • Change of systemic inflammatory response

    Time 0 and after 60 days

  • Change of cognitive function

    Time 0 and after 60 days

Study Arms (2)

Rifaximin

EXPERIMENTAL

Rifaximin 550 mg 1 tablet BID for 60 days

Drug: Rifaximin

Placebo

PLACEBO COMPARATOR

Placebo 1 tablet BID for +60 days

Drug: Placebo

Interventions

RifaximinDRUG

Rifaximin 550 mg tablet BID for 60 days

Rifaximin
PlaceboDRUG

Placebo 1 tablet BID for 60 days

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of liver cirrhosis (based on clinical, biochemical and radiological criteria with or without liver biopsy)
  • Presence of esophageal varices at high risk of bleeding
  • Hepatic Venous Pressure Gradient \> 12 mmHg.
  • ≤ age ≤75
  • Informed Consent

You may not qualify if:

  • Patients already treated with beta blockers
  • Treatment with systemic antibiotics and/or non-absorbable intestinal antibiotics in the previous two weeks
  • Bacterial infection, spontaneous bacterial peritonitis
  • overt hepatic encephalopathy in the last week
  • active gastrointestinal bleeding, or in the last week
  • active alcoholism or drug abuse in last 3 weeks
  • Acute Alcoholic Hepatitis
  • Hepatocellular carcinoma or other neoplasm
  • significant coronary artery disease (angina NYHA III/IV), congestive heart failure (NYHA III/IV), relevant cardiomyopathy, history of myocardial infarct within the last 12 months
  • Contraindications to the administration of beta blockers; allergy to Rifaximin
  • Pregnancy or breastfeeding
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera di Padova

Padua, Italy, 35140, Italy

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisHypertension, Portal

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Piero Amodio

    University of Padova

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Campagna, MD

CONTACT

+39 0498218675francescacampagna3@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 27, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2017

Study Completion

July 1, 2017

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

IT(1)