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Recruiting Phase 3 NCT04161053

NCT04161053 Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

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Clinical Trial Summary
NCT ID NCT04161053
Status Recruiting
Phase Phase 3
Sponsor Tanta University
Condition Hepatic Encephalopathy
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2018-11-01
Primary Completion 2028-11

Eligibility & Interventions

Sex All sexes
Min Age 20 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
RifaximinNitazoxanide

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 60 participants in total. It began in 2018-11-01 with a primary completion date of 2028-11.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Efficacy and Safety of Nitazoxanide in preventing recurrence of 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).

Contact & Investigator

Central Contact

Sherief Abd-Elsalam, ass. prof.

✉ sheriefabdelsalam@yahoo.com

📞 00201147773440

Principal Investigator

Khadija Ahmed Glal, Msc

PRINCIPAL INVESTIGATOR

Tanta University

Frequently Asked Questions

Who can join the NCT04161053 clinical trial?

This trial is open to participants of all sexes, aged 20 Years or older, up to 65 Years, studying Hepatic Encephalopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT04161053 trial and what does that mean for participants?

Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.

Is NCT04161053 currently recruiting?

Yes, NCT04161053 is actively recruiting participants. Contact the research team at sheriefabdelsalam@yahoo.com for enrollment information.

Where is the NCT04161053 trial being conducted?

This trial is being conducted at Tanta, Egypt.

Who is sponsoring the NCT04161053 clinical trial?

NCT04161053 is sponsored by Tanta University. The principal investigator is Khadija Ahmed Glal, Msc at Tanta University. The trial plans to enroll 60 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology