The Effects of Nitazoxanide in Hepatic Encephalopathy

January 7, 2015 updated by: Asmaa Abdel Aziz ElRakaybi, Ain Shams University

The Clinical Effects of Nitazoxanide in Hepatic Encephalopathy Patients: A Pilot Study

Evaluating the efficacy and safety of nitazoxanide in comparison to standard treatment in patients with grade II-III hepatic encephalopathy (HE). Also, Evaluating the effect of administering nitazoxanide on the improvement of patient's quality of life.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Nitazoxanide (NTZ) is a thiazolide anti-infective with activity against anaerobic bacteria, protozoa and viruses. A pilot prospective study at the 2008 American Association for the Study of Liver Diseases meeting showing clinical improvement in HE among cirrhotic patients who received nitazoxanide and lactulose. Based on the excellent safety profile of NTZ, the present pilot study is conducted hopefully to prove the efficacy of nitazoxanide in treating patients experiencing HE grade II-III.

Study design:The study is Prospective, Randomized, Controlled, Open-Label, Pilot study.

Method: The study will include a total of 36 patients with grade II-III Hepatic Encephalopathy, and an informed consent will be obtained from every patient before being included.

All the patients will receive oral lactulose, plus either nitazoxanide, metronidazole or rifaximine.

A- All patients will be subjected to the following at baseline:

  • Patient's full history
  • Liver disease staging using Model for End stage Liver Disease (MELD) score
  • Measurement of serum electrolytes (Na+, K+, Ca2+)

B- All patients will be subjected to the following at baseline and at the end of treatment:

  • Measuring Blood ammonia level
  • Measuring liver function tests (AST, Total bilirubin, international normalized ratio (INR), Serum albumin, prothrombin time (PT)), serum creatinine and complete blood count (CBC)
  • Assessing severity of Hepatic Encephalopathy using Clinical Hepatic Encephalopathy Staging Scale (CHESS)

C- Monitoring tolerability up to 30 days after the last dose D- Assessment of quality of life using Chronic Liver Disease Questionnaire (CLDQ)

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2

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 Locations

  • Egypt
      • Cairo, Egypt, 1156
        • Recruiting
        • Faculty of Medicine, Ain Shams University
        • Contact:
        • Principal Investigator:
          • Asmaa A. Elrakaybi, Bachelor

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult Patients from 18 to 65 years.
  • Patients with grade II-III Hepatic Encephalopathy.

Exclusion Criteria:

  • Patients with active GIT bleeding.
  • Patients with major psychiatric illness.
  • Patients receiving benzodiazepines, narcotics, alcohol and marijuana.
  • Patients with compromised renal or biliary functions.
  • Patients known to have AIDS.
  • Patients receiving medications highly bound to plasma proteins eg. Warfarin.
  • Patients with known hypersensitivity to nitazoxanide.
  • Pregnant or lactating women.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nitazoxanide group

12 patients will receive the following for 7 days:

  • Oral lactulose
  • 500 mg nitazoxanide tablets twice daily
Drug: Nitazoxanide
500 mg nitazoxanide tablets twice daily
Drug: Oral lactulose
Oral lactulose (65%)
Active Comparator: Metronidazole group

12 patients will receive the following for 7 days:

  • Oral lactulose
  • 250 mg metronidazole tablets every 8 hours
Drug: Oral lactulose
Oral lactulose (65%)
Drug: Metronidazole
250 mg metronidazole tablets every 8 hours
Active Comparator: Rifaximine group

12 patients will receive the following for 7 days:

  • Oral lactulose
  • Two 200 mg rifaximine tablets every 8 hours
Drug: Oral lactulose
Oral lactulose (65%)
Drug: Rifaximine
Two 200 mg rifaximine tablets every 8 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the efficacy of nitazoxanide in improving mental status (calculating CHESS score)
Time Frame: 7 days
evaluating the efficacy by measuring serum ammonia and calculating CHESS score at baseline and at end of treatment
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the safety of nitazoxanide (estimation of treatment- related undesirable effects)
Time Frame: 37 days
Evaluating the safety of nitazoxanide by estimation of treatment- related undesirable effects
37 days
Effect of nitazoxanide on patient's quality of life (CLDQ score)
Time Frame: 7 days
Evaluating the effect on quality of life by calculating CLDQ score at baseline and at end of treatment
7 days

Collaborators and Investigators

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

Sponsor

Ain Shams University

Collaborators

Al-Azhar University

Investigators

  • Principal Investigator: Asmaa A. Elrakaybi, Bachelor, ain shams University

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

December 1, 2014

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

January 7, 2015

First Posted (Estimate)

January 8, 2015

Study Record Updates

Last Update Posted (Estimate)

January 8, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHCL400

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.

Clinical Trials on Hepatic Encephalopathy

Clinical Trials on Nitazoxanide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe