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Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Primary Purpose

Hepatic Encephalopathy

Status

Recruiting

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Rifaximin

Nitazoxanide

About this trial

This is an interventional prevention trial for Hepatic Encephalopathy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Sherief Abd-ElsalamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rifaximin

Nitazoxanide

Arm Description

550 mg Rifaximin tablets twice daily for six months.

500 mg Nitazoxanide tablets twice daily for six months.

Outcomes

Primary Outcome Measures

Number of encephalopathy episodes during treatment

The number of encephalopathy episodes during treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT04161053

First Posted

November 8, 2019

Last Updated

November 12, 2019

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT04161053

Brief Title

Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2018 (Actual)

Primary Completion Date

November 2028 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Encephalopathy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rifaximin

Arm Type

Active Comparator

Arm Description

550 mg Rifaximin tablets twice daily for six months.

Arm Title

Nitazoxanide

Arm Type

Experimental

Arm Description

500 mg Nitazoxanide tablets twice daily for six months.

Intervention Type

Drug

Intervention Name(s)

Rifaximin

Other Intervention Name(s)

Gastrobiotic, Trencedia

Intervention Description

Rifaximin 550 mg twice daily for 6 months

Intervention Type

Drug

Intervention Name(s)

Nitazoxanide

Other Intervention Name(s)

Nanazoxid

Intervention Description

Nitazoxanide 500 mg twice daily for 6 months

Primary Outcome Measure Information:

Title

Number of encephalopathy episodes during treatment

Description

The number of encephalopathy episodes during treatment

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sherief Abd-Elsalam, ass. prof.

Phone

00201147773440

sheriefabdelsalam@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

sherief abd-elsalam, ass. prof.

Phone

00201147773440

sherif_tropical@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Khadija Ahmed Glal, Msc

Organizational Affiliation

faculty of pharmacy- Tanta University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tarek Mohamed Mostafa, ass, Prof.

Organizational Affiliation

faculty of pharmacy- Tanta University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sherief Abd-Elsalam, Ass. Prof.

Organizational Affiliation

Tanta University - Tropical Medicine Department

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sherief Abd-Elsalam

City

Tanta

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherief Abd-Elsalam

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

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