The Effects of Nitazoxanide in Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02334163
• Other study ID #: PHCL400
• Status: Recruiting
• Phase: Phase 2
• First received: January 6, 2015
• Last updated: January 7, 2015
• Start date: December 2014
• Est. completion date: April 2015

Study information

• Verified date: January 2015
• Source: Ain Shams University
• Contact: Amal T. Abd ElMoez, PhD
• Email: d_amal_tohamy[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult Patients from 18 to 65 years.

• Patients with grade II-III Hepatic Encephalopathy.

Exclusion Criteria:

• Patients with active GIT bleeding.

• Patients with major psychiatric illness.

• Patients receiving benzodiazepines, narcotics, alcohol and marijuana.

• Patients with compromised renal or biliary functions.

• Patients known to have AIDS.

• Patients receiving medications highly bound to plasma proteins eg. Warfarin.

• Patients with known hypersensitivity to nitazoxanide.

• Pregnant or lactating women.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Drug:
• Nitazoxanide
500 mg nitazoxanide tablets twice daily
• Oral lactulose
Oral lactulose (65%)
• Metronidazole
250 mg metronidazole tablets every 8 hours
• Rifaximine
Two 200 mg rifaximine tablets every 8 hours

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Ain Shams University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the efficacy of nitazoxanide in improving mental status (calculating CHESS score)	evaluating the efficacy by measuring serum ammonia and calculating CHESS score at baseline and at end of treatment	7 days	No
Secondary	Evaluating the safety of nitazoxanide (estimation of treatment- related undesirable effects)	Evaluating the safety of nitazoxanide by estimation of treatment- related undesirable effects	37 days	Yes
Secondary	Effect of nitazoxanide on patient's quality of life (CLDQ score)	Evaluating the effect on quality of life by calculating CLDQ score at baseline and at end of treatment	7 days	No