NCT03077217

Brief Summary

Several studies have been showed that rifaximin can improve cognitive functions, driving simulator performance and health-related quality of life in patients with minimal hepatic encephalopathy. The aim of this prospective randomized open controlled study was to evaluate the efficacy and safety of rifaximin at different doses for the treatment of covert hepatic encephalopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 30, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

3.1 years

First QC Date

January 30, 2017

Last Update Submit

June 28, 2021

Conditions

Covert Hepatic Encephalopathy

Keywords

covert hepatic encephalopathylow-dose rifaximin

Outcome Measures

Primary Outcomes (2)

  • Percentage of patients showing covert hepatic encephalopathy reversal

    the percentage of patients showing covert hepatic encephalopathy reversal

    up to 6 months

  • health-related quality of life improvement

    complete the questionnaire "sickness impact profile"

    up to 6 month

Study Arms (3)

the high-dose rifaximin

ACTIVE COMPARATOR

The high-dose rifaximin group was given rifaximin 1200 mg/day for 8 weeks.

Drug: Rifaximin

the low-dose rifaximinl group

ACTIVE COMPARATOR

The low-dose rifaximin group was given rifaximin 800 mg/day for 8 weeks.

Drug: Rifaximin

the control group

PLACEBO COMPARATOR

The control group didn't receive rifaximin treatment

Drug: Rifaximin

Interventions

RifaximinDRUG

The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy

the control groupthe high-dose rifaximinthe low-dose rifaximinl group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients agreed to sign the informed consents
  • Patients aged 18-70 years，males or females
  • Patients who were diagnosed with occult hepatic encephalopathy by PHES and Stroop tests

You may not qualify if:

  • Allergy to rifamycin/rifamutin/rifampin/rifapentine
  • Current or recent (\<3 month) use of alcohol or can't stop drinking during the study period
  • Use of antibiotics within last 6 weeks
  • Use of lactulose/lactitol, probiotics, L-ornithine-L-aspart，zinc，metronidazole, neomycin, or rifaximin within last 6 weeks
  • Infection or gastrointestinal hemorrhage within last 6 weeks
  • Use of psychoactive drugs within last 6 weeks
  • Occurred overt hepatic encephalopathy within last 3 months
  • history of portosystemic shunt surgery or transjugular intrahepatic portosystemic shunt
  • Poor vision, color blindness or motor defects that interfere with the performance of psychometric tests
  • Other non-controllable neurological or psychiatric problems which may affect cognitive function such as Alzheimer's disease, Parkinson's disease or schizophrenia
  • Conformed or highly suspicious diagnosis of liver malignant tumors
  • Human immunodeficiency virus (HIV) infection
  • Uncontrolled hypertension, diabetes or other serious cardiac and pulmonary diseases
  • White blood cell count\<1×10\^9/L
  • Pregnancy and breastfeeding
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

Related Publications (1)

  • Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.

    PMID: 37467180DERIVED

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 30, 2017

First Posted

March 10, 2017

Study Start

May 1, 2017

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)