Clinical Trials Logo
  1. Home
  2. Hepatic Encephalopathy
  3. NCT04161053
  4. Details
NCT04161053 Clinical Trial

Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04161053
Other study ID # Encephalopathy
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 1, 2018
Est. completion date December 2028

Study information
Verified date November 2019
Source Tanta University
Contact Sherief Abd-Elsalam, ass. prof.
Phone 00201147773440
Email sheriefabdelsalam@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2028
Est. primary completion date November 2028
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rifaximin
Rifaximin 550 mg twice daily for 6 months
• Nitazoxanide
Nitazoxanide 500 mg twice daily for 6 months

Locations
Country Name City State
Egypt Sherief Abd-Elsalam Tanta

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of encephalopathy episodes during treatment The number of encephalopathy episodes during treatment 6 months
See also
  Status Clinical Trial Phase
Completed NCT01559519 - Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy Phase 4
Terminated NCT01846806 - The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy. N/A
Recruiting NCT01178372 - Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis Phase 4
Completed NCT00740142 - Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy Phase 4
Completed NCT00914056 - A Study of Controlled Lactulose Withdrawal N/A
Completed NCT00558038 - Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy Phase 2
Completed NCT00986895 - A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group Phase 1
Completed NCT00287235 - Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS) N/A
Recruiting NCT05539027 - Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy Phase 4
Recruiting NCT04096014 - Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy N/A
Completed NCT05526404 - Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration N/A
Completed NCT04082780 - Rifamycin in Minimal Hepatic Encephalopathy Phase 2
Enrolling by invitation NCT06367127 - Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening
Active, not recruiting NCT05425316 - Speech in Hepatic Encephalopathy (HE)
Recruiting NCT04415294 - Flicker App for Minimal Hepatic Encephalopathy
Not yet recruiting NCT06072521 - Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy Phase 2
Completed NCT02636647 - Fecal Transplant in Recurrent Hepatic Encephalopathy Phase 1
Withdrawn NCT02086825 - A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure Phase 3
Completed NCT01446523 - S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE N/A
Completed NCT01218568 - Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial N/A