NCT04161053 is a Phase 3 clinical trial of Rifaximin in Hepatic Encephalopathy, sponsored by Tanta University.

Who is sponsoring NCT04161053?

NCT04161053 is sponsored by Tanta University.

What drugs are being tested in NCT04161053?

Interventions in NCT04161053: Rifaximin, Nitazoxanide.

What condition does NCT04161053 study?

NCT04161053 studies Hepatic Encephalopathy.

Is NCT04161053 still recruiting?

NCT04161053 is currently recruiting now. Last updated 12 November 2019.

Last reviewed 2019-11-12 · How we verify

NCT04161053

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 12 November 2019

What this trial tests

Phase 3 trial testing Rifaximin in Hepatic Encephalopathy in 60 participants. Currently enrolling.

Timeline

1 November 2018

Primary endpoint
1 November 2028

1 December 2028

Quick facts

Lead sponsor	Tanta University
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	60
Start date	1 November 2018
Primary completion	1 November 2028
Estimated completion	1 December 2028
Sites	1 location across Egypt

Drugs / interventions tested

Rifaximin (rifaximin) — full drug profile →
Nitazoxanide (NITAZOXANIDE) — full drug profile →

Conditions studied

Hepatic Encephalopathy — all drugs for Hepatic Encephalopathy →

Sponsor

Tanta University

Who can join

Adults 20 to 65, any sex, with Hepatic Encephalopathy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of encephalopathy episodes during treatment
Time frame: 6 months
The number of encephalopathy episodes during treatment

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Pharmacotherapy for Non-Alcoholic Fatty Liver Disease: Emerging Targets and Drug Candidates.
Prikhodko VA, Bezborodkina NN, Okovityi SV. · · 2022 · cited 33× · PMID 35203484 · DOI 10.3390/biomedicines10020274
Active Clinical Trials in Hepatic Encephalopathy: Something Old, Something New and Something Borrowed.
Balzano T. · · 2023 · cited 6× · PMID 36977964 · DOI 10.1007/s11064-023-03916-w
Future Therapies of Hepatic Encephalopathy.
Buckholz AP, Brown RS. · · 2024 · cited 5× · PMID 38548443 · DOI 10.1016/j.cld.2024.02.002

Verify or expand the search:

Other trials of Rifaximin

Trials testing the same drug.

NCT07209371 — Rifaximin Versus No Intervention for the Treatment of IgA Monoclonal Gammopathy of Undetermined Significance · Phase 2 · recruiting
NCT07203846 — Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor · Phase 4 · not yet recruiting
NCT06483737 — Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE) · NA · recruiting
NCT06808009 — Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Re · NA · not yet recruiting
NCT06652087 — Rifaximin and Cardiac Function in Patients with Heart Failure with Preserved Ejection Fraction · NA · recruiting

Other recruiting trials for Hepatic Encephalopathy

Currently open trials in the same condition.

NCT07521332 — Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis · Phase 4 · recruiting
NCT07418008 — The Liver Cirrhosis Cognitive Decline Scale (LiCCoS) · recruiting
NCT06953921 — Correlation Between Serum Albumin Level and Severity of Hepatic Encephalopathy in Patients With Chronic Liver Disease in · recruiting
NCT07437638 — Clinical Efficacy and Survival Prediction Analysis of Transjugular Intrahepatic Portosystemic Shunt in Patients With Liv · active not recruiting
NCT06425380 — Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy · NA · recruiting

Other Tanta University trials

Trials by the same sponsor.

NCT07398651 — Apremilast and Adalimumab in Psoriatic Arthritis Patients · NA · not yet recruiting
NCT06966856 — This Randomized, Clinical Trial Evaluates the Efficacy of Oral Versus Sublingual Vitamin B12 Supplementation in Correcti · Phase 3 · not yet recruiting
NCT07334197 — Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy · NA · not yet recruiting
NCT07498998 — Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome · NA · not yet recruiting
NCT07114250 — Comparative Study Between Spinal Anesthesia Versus General Anesthesia in Supine Percutaneous Nephrolithotomy Operation · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04161053 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tanta University
Last refreshed: 12 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04161053.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing