Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

NCT ID: NCT04161053

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2028-12-31

Brief Summary

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Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.

Detailed Description

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Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.

Conditions

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Hepatic Encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rifaximin

550 mg Rifaximin tablets twice daily for six months.

Group Type ACTIVE_COMPARATOR

Rifaximin

Intervention Type DRUG

Rifaximin 550 mg twice daily for 6 months

Nitazoxanide

500 mg Nitazoxanide tablets twice daily for six months.

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

Nitazoxanide 500 mg twice daily for 6 months

Interventions

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Rifaximin

Rifaximin 550 mg twice daily for 6 months

Intervention Type DRUG

Nitazoxanide

Nitazoxanide 500 mg twice daily for 6 months

Intervention Type DRUG

Other Intervention Names

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Gastrobiotic, Trencedia Nanazoxid

Eligibility Criteria

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Inclusion Criteria

* Cirrhotic patient with at least one previous episode of hepatic encephalopathy.
* Adult Patients aging from 20 to 65 years old

Exclusion Criteria

* Active GIT bleeding.
* Major psychiatric illness (psychosis \& epilepsy).
* Renal insufficiency (S.Cr 2mg/dl).
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Ass. Prof. Tropical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khadija Ahmed Glal, Msc

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Tarek Mohamed Mostafa, ass, Prof.

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Sherief Abd-Elsalam, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Tanta University - Tropical Medicine Department

Locations

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Sherief Abd-Elsalam

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, ass. prof.

Role: CONTACT

00201147773440

sherief abd-elsalam, ass. prof.

Role: CONTACT

00201147773440

Facility Contacts

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Sherief Abd-Elsalam

Role: primary

Other Identifiers

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Encephalopathy

Identifier Type: -

Identifier Source: org_study_id

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