NCT02334163

The Effects of Nitazoxanide in Hepatic Encephalopathy

The Clinical Effects of Nitazoxanide in Hepatic Encephalopathy Patients: A Pilot Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Evaluating the efficacy and safety of nitazoxanide in comparison to standard treatment in patients with grade II-III hepatic encephalopathy (HE). Also, Evaluating the effect of administering nitazoxanide on the improvement of patient's quality of life.

Detailed description

Nitazoxanide (NTZ) is a thiazolide anti-infective with activity against anaerobic bacteria, protozoa and viruses. A pilot prospective study at the 2008 American Association for the Study of Liver Diseases meeting showing clinical improvement in HE among cirrhotic patients who received nitazoxanide and lactulose. Based on the excellent safety profile of NTZ, the present pilot study is conducted hopefully to prove the efficacy of nitazoxanide in treating patients experiencing HE grade II-III. Study design:The study is Prospective, Randomized, Controlled, Open-Label, Pilot study. Method: The study will include a total of 36 patients with grade II-III Hepatic Encephalopathy, and an informed consent will be obtained from every patient before being included. All the patients will receive oral lactulose, plus either nitazoxanide, metronidazole or rifaximine. A- All patients will be subjected to the following at baseline: * Patient's full history * Liver disease staging using Model for End stage Liver Disease (MELD) score * Measurement of serum electrolytes (Na+, K+, Ca2+) B- All patients will be subjected to the following at baseline and at the end of treatment: * Measuring Blood ammonia level * Measuring liver function tests (AST, Total bilirubin, international normalized ratio (INR), Serum albumin, prothrombin time (PT)), serum creatinine and complete blood count (CBC) * Assessing severity of Hepatic Encephalopathy using Clinical Hepatic Encephalopathy Staging Scale (CHESS) C- Monitoring tolerability up to 30 days after the last dose D- Assessment of quality of life using Chronic Liver Disease Questionnaire (CLDQ)

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	Nitazoxanide	500 mg nitazoxanide tablets twice daily
DRUG	Oral lactulose	Oral lactulose (65%)
DRUG	Metronidazole	250 mg metronidazole tablets every 8 hours
DRUG	Rifaximine	Two 200 mg rifaximine tablets every 8 hours

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-02-01
• Completion: 2015-04-01
• First posted: 2015-01-08
• Last updated: 2015-01-08

Locations

1 site across 1 country: Egypt