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
Sponsored by
About this trial
This is an interventional prevention trial for Hepatic Encephalopathy
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).
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
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
Email
sheriefabdelsalam@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
sherief abd-elsalam, ass. prof.
Phone
00201147773440
Email
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
No
Learn more about this trial
Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy
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