Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Phase 3

Recruiting

• Conditions: Hepatic Encephalopathy
• Interventions: Drug: Nitazoxanide; Drug: Rifaximin

• Registration Number: NCT04161053
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2018-11-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-12
• Last Update Submitted: 2019-11-12
• Study First Posted: 2019-11-13
• Last Update Posted: 2019-11-13
• Primary Completion: 2028-11
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitazoxanide	Nitazoxanide	500 mg Nitazoxanide tablets twice daily for six months.
Rifaximin	Rifaximin	550 mg Rifaximin tablets twice daily for six months.

Primary Outcome Measures

Name	Time	Method
Number of encephalopathy episodes during treatment	6 months	The number of encephalopathy episodes during treatment

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Tanta, Egypt