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NCT04161053 Clinical Trial

Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04161053
Other study ID # Encephalopathy
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 1, 2018
Est. completion date December 2028

Study information
Verified date November 2019
Source Tanta University
Contact Sherief Abd-Elsalam, ass. prof.
Phone 00201147773440
Email sheriefabdelsalam@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2028
Est. primary completion date November 2028
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Rifaximin
Rifaximin 550 mg twice daily for 6 months
• Nitazoxanide
Nitazoxanide 500 mg twice daily for 6 months

Locations
Country Name City State
Egypt Sherief Abd-Elsalam Tanta

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of encephalopathy episodes during treatment The number of encephalopathy episodes during treatment 6 months
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