Efficacy and Safety of Nitazoxanide in Preventing Recurre... | NCT04161053

Studies
Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

NCT04161053

Sponsor

Tanta University

Status

Recruiting

Last Update Posted

Nov 13, 2019Actual

Enrollment

60Estimated

Phase

Phase 3

Conditions

Hepatic Encephalopathy

Interventions

Rifaximin
Nitazoxanide

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2018Actual

Primary Completion Date

Nov 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Nov 8, 2019

First Submission Date that Met QC Criteria

Nov 12, 2019

First Posted Date

Nov 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2019

Last Update Posted Date

Nov 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rifaximin	Drug	Rifaximin 550 mg twice daily for 6 months	Rifaximin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of encephalopathy episodes during treatment	The number of encephalopathy episodes during treatment	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, ass. prof.	Contact	00201147773440		sheriefabdelsalam@yahoo.com
sherief abd-elsalam, ass. prof.	Contact	00201147773440		sherif_tropical@yahoo.com

Overall Officials

Name	Affiliation	Role
Khadija Ahmed Glal, Msc	Tanta University	Principal Investigator
Tarek Mohamed Mostafa, ass, Prof.	Tanta University	Principal Investigator
Sherief Abd-Elsalam, Ass. Prof.

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sherief Abd-Elsalam	Recruiting	Tanta			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006501	Hepatic Encephalopathy

Ancestor Terms

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078262	Rifaximin
C041747	nitazoxanide

Ancestor Terms

ID	Term
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided