The Effects of Nitazoxanide in Hepatic Encephalopathy

Ain Shams University

Status and phase: Unknown; Phase 2

Conditions: Hepatic Encephalopathy

Treatments: Drug: Oral lactulose; Drug: Metronidazole; Drug: Nitazoxanide; Drug: Rifaximine

Study type: Interventional

Funder types: Other

Identifiers

NCT02334163

PHCL400

Details and patient eligibility

About

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.

Full 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)

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Nitazoxanide group

Experimental group

Description:

12 patients will receive the following for 7 days: * Oral lactulose * 500 mg nitazoxanide tablets twice daily

Treatment:

Drug: Oral lactulose

Drug: Nitazoxanide

Metronidazole group

Active Comparator group

Description:

12 patients will receive the following for 7 days: * Oral lactulose * 250 mg metronidazole tablets every 8 hours

Treatment:

Drug: Oral lactulose

Drug: Metronidazole

Rifaximine group

Active Comparator group

Description:

12 patients will receive the following for 7 days: * Oral lactulose * Two 200 mg rifaximine tablets every 8 hours

Treatment:

Drug: Oral lactulose

Drug: Rifaximine