NCT04161053

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
31mo left

Started Nov 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Nov 2018Dec 2028

Study Start

First participant enrolled

November 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

10 years

First QC Date

November 8, 2019

Last Update Submit

November 12, 2019

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

  • Number of encephalopathy episodes during treatment

    The number of encephalopathy episodes during treatment

    6 months

Study Arms (2)

Rifaximin

ACTIVE COMPARATOR

550 mg Rifaximin tablets twice daily for six months.

Drug: Rifaximin

Nitazoxanide

EXPERIMENTAL

500 mg Nitazoxanide tablets twice daily for six months.

Drug: Nitazoxanide

Interventions

RifaximinDRUG

Rifaximin 550 mg twice daily for 6 months

Also known as: Gastrobiotic, Trencedia
Rifaximin
NitazoxanideDRUG

Nitazoxanide 500 mg twice daily for 6 months

Also known as: Nanazoxid
Nitazoxanide

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cirrhotic patient with at least one previous episode of hepatic encephalopathy.
  • Adult Patients aging from 20 to 65 years old

You may not qualify if:

  • Active GIT bleeding.
  • Major psychiatric illness (psychosis \& epilepsy).
  • Renal insufficiency (S.Cr 2mg/dl).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Rifaximinnitazoxanide

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Khadija Ahmed Glal, Msc

    Tanta University

    PRINCIPAL INVESTIGATOR

  • Tarek Mohamed Mostafa, ass, Prof.

    Tanta University

    PRINCIPAL INVESTIGATOR

  • Sherief Abd-Elsalam, Ass. Prof.

    Tanta University - Tropical Medicine Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

sherief abd-elsalam, ass. prof.

CONTACT

00201147773440sherif_tropical@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 13, 2019

Study Start

November 1, 2018

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)