Clinical trial NCT02334163: The Effects of Nitazoxanide in Hepatic Encephalopathy
Official title: The Clinical Effects of Nitazoxanide in Hepatic Encephalopathy Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatic Encephalopathy
Keywords: Hepatic Encephalopathy
Nitazoxanide
Serum ammonia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Al-Azhar University
First posted: 2015-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluating the efficacy of nitazoxanide in improving mental status (calculating CHESS score)
timeFrame: 7 days
Secondary outcomes:
measure: Evaluating the safety of nitazoxanide (estimation of treatment- related undesirable effects)
timeFrame: 37 days
measure: Effect of nitazoxanide on patient's quality of life (CLDQ score)
timeFrame: 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Asmaa A. Elrakaybi, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: