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NCT Number: NCT04161053

Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

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

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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sherief Abd-Elsalam

Tanta, Egypt

Location status: Recruiting

Location contact

Sherief Abd-Elsalam

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rifaximin

Drug

Rifaximin 550 mg twice daily for 6 months

Other names: Gastrobiotic, Trencedia

Nitazoxanide

Drug

Nitazoxanide 500 mg twice daily for 6 months

Other names: Nanazoxid

Primary outcomes

  1. Number of encephalopathy episodes during treatment

    Time frame: 6 months

    The number of encephalopathy episodes during treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Sherief Abd-Elsalam, ass. prof.

CONTACT

[email protected]

00201147773440

sherief abd-elsalam, ass. prof.

CONTACT

[email protected]

00201147773440

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Nov 13, 2019
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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