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Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy

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ClinicalTrials.gov Identifier: NCT03077217
Recruitment Status : Unknown
Verified March 2017 by Wei-Fen Xie, Shanghai Changzheng Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 10, 2017
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Wei-Fen Xie, Shanghai Changzheng Hospital

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.

Condition or disease Intervention/treatment Phase
Covert Hepatic Encephalopathy Drug: Rifaximin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy: A Randomized Open Controlled Study
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arm Intervention/treatment
Active Comparator: high-dose rifaximin Drug: Rifaximin
The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy

No Intervention: control group



Primary Outcome Measures :
  1. Percentage of patients showing covert hepatic encephalopathy reversal [ Time Frame: up to 6 months ]
    the percentage of patients showing covert hepatic encephalopathy reversal

  2. health-related quality of life improvement [ Time Frame: up to 6 month ]
    complete the questionnaire "sickness impact profile"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Allergy to rifamycin/rifamutin/rifampin/rifapentine
  2. Current or recent (<3 month) use of alcohol or can't stop drinking during the study period
  3. Use of antibiotics within last 6 weeks
  4. Use of lactulose/lactitol, probiotics, L-ornithine-L-aspart,zinc,metronidazole, neomycin, or rifaximin within last 6 weeks
  5. Infection or gastrointestinal hemorrhage within last 6 weeks
  6. Use of psychoactive drugs within last 6 weeks
  7. Occurred overt hepatic encephalopathy within last 3 months
  8. history of portosystemic shunt surgery or transjugular intrahepatic portosystemic shunt
  9. Poor vision, color blindness or motor defects that interfere with the performance of psychometric tests
  10. Other non-controllable neurological or psychiatric problems which may affect cognitive function such as Alzheimer's disease, Parkinson's disease or schizophrenia
  11. Conformed or highly suspicious diagnosis of liver malignant tumors
  12. Human immunodeficiency virus (HIV) infection
  13. Uncontrolled hypertension, diabetes or other serious cardiac and pulmonary diseases
  14. White blood cell count<1×10^9/L
  15. Pregnancy and breastfeeding
  16. Participated in other drug clinical trials within 3 months
  17. The researchers thought it was not suitable for this clinical trial

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Responsible Party: Wei-Fen Xie, Director, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT03077217     History of Changes
Other Study ID Numbers: CZH0010
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wei-Fen Xie, Shanghai Changzheng Hospital:
covert hepatic encephalopathy
low-dose rifaximin
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents