Using Nitazoxanide to prevent recurrence of hepatic encephalopathy
Official title: Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy
Run by Tanta University · NCT04161053 · Data updated 2026-11-12
This study is testing if a medication called Nitazoxanide can help prevent cirrhotic patients from having more episodes of hepatic encephalopathy when used with another drug called Rifaximin.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Status | Recruiting |
| Started | November 1, 2018 |
| Main results expected | November 2028 |
| Study ends | December 2028 |
| Registry record updated | November 13, 2019 |
| Trial ID | NCT04161053 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are cirrhotic patients aged 20 to 65 who have experienced at least one previous episode of hepatic encephalopathy.
✕Probably not a fit
Patients with active gastrointestinal bleeding, major psychiatric illnesses, or renal insufficiency are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the efficacy and safety of Nitazoxanide in preventing the recurrence of hepatic encephalopathy in cirrhotic patients. The study involves administering Nitazoxanide alongside Rifaximin to assess its effectiveness in reducing the frequency of episodes in patients who have previously experienced hepatic encephalopathy. Participants will be monitored for safety and efficacy throughout the trial period. The study aims to provide a potential new treatment option for managing this serious condition.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence of hepatic encephalopathy in patients, improving their quality of life.
How similar studies have gone: Other studies have explored treatments for hepatic encephalopathy, but the specific use of Nitazoxanide in this context is novel.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
-
Sherief Abd-Elsalam
Tanta, Egypt Recruiting
Study contacts
- Principal investigator: Khadija Ahmed Glal, Msc — Tanta University
- Study coordinator: Sherief Abd-Elsalam, ass. prof.
- Email: sheriefabdelsalam@yahoo.com
- Phone: 00201147773440
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Coil-assisted small-diameter stent shunt reduction for refractory HE after TIPS
A coil-assisted, small-diameter covered-stent technique is being tested to see if it can safely and effectively reduce shunt flow and lessen recurrent hepatic encephalopathy in people with a prior TIPS.
-
Fecal transplant plus standard therapy for refractory hepatic encephalopathy after TIPS
This study tests whether adding fecal microbiota transplantation to usual medicines helps people with recurrent hepatic encephalopathy after TIPS implant.
-
Apixaban plus carvedilol to prevent portal-hypertension complications in cirrhosis
This will test whether adding apixaban to carvedilol can help prevent variceal bleeding, portal vein thrombosis, and other portal-hypertension complications in adults with Child-Pugh B cirrhosis.
-
Developing and testing the Liver Cirrhosis Cognitive Decline Scale (LiCCoS)
This project will test a short questionnaire called LiCCoS to see if it can spot thinking and everyday mental problems in adults with liver cirrhosis.
-
Melatonin to improve sleep and thinking in people with cirrhosis
This study will try one month of daily melatonin (compared with one month of thiamine) to see if it improves sleep and thinking in adults with cirrhosis and hepatic encephalopathy.
-
Examining the link between serum albumin levels and hepatic encephalopathy severity in chronic liver disease patients
This study is trying to see if the level of a protein called serum albumin in the blood is related to how severe brain problems are in people with chronic liver disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.