Using Nitazoxanide to prevent recurrence of hepatic encephalopathy
Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy
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 |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT04161053 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are cirrhotic patients aged 20 to 65 who have experienced at least one previous episode of hepatic encephalopathy.
Not a fit: Patients with active gastrointestinal bleeding, major psychiatric illnesses, or renal insufficiency are unlikely to benefit from this study.
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 performed: Other studies have explored treatments for hepatic encephalopathy, but the specific use of Nitazoxanide in this context is novel.
Eligibility criteria
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 this trial is running
Tanta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.