Hepatic EncephalopathyPhase 2NCT02334163
The Effects of Nitazoxanide in Hepatic Encephalopathy
A Phase 2 study testing Nitazoxanide, Oral lactulose and Metronidazole in people with Hepatic Encephalopathy, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- Nitazoxanide, Oral lactulose and Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2014to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients from 18 to 65 years.
- Patients with grade II-III Hepatic Encephalopathy.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Amal T. Abd ElMoez, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine, Ain Shams University
Cairo, 1156
Amal T. Abd ElMoez, PhD, d_amal_tohamy@yahoo.com
Asmaa A. Elrakaybi, Bachelor
About this study
Official title: The Clinical Effects of Nitazoxanide in Hepatic Encephalopathy Patients: A Pilot Study
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.
Read the 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
- Being tested
- Nitazoxanide, Oral lactulose, Metronidazole, Rifaximine
- Keywords
- Hepatic Encephalopathy, Nitazoxanide, Serum ammonia
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
500 mg nitazoxanide tablets twice daily
Oral lactuloseDrug
Oral lactulose (65%)
MetronidazoleDrug
250 mg metronidazole tablets every 8 hours
RifaximineDrug
Two 200 mg rifaximine tablets every 8 hours
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide group | Experimental | 12 patients will receive the following for 7 days:
* Oral lactulose
* 500 mg nitazoxanide tablets twice daily Receives: Drug: Nitazoxanide; Drug: Oral lactulose |
| Metronidazole group | Active comparator | 12 patients will receive the following for 7 days:
* Oral lactulose
* 250 mg metronidazole tablets every 8 hours Receives: Drug: Oral lactulose; Drug: Metronidazole |
| Rifaximine group | Active comparator | 12 patients will receive the following for 7 days:
* Oral lactulose
* Two 200 mg rifaximine tablets every 8 hours Receives: Drug: Oral lactulose; Drug: Rifaximine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (2)
Evaluating the safety of nitazoxanide (estimation of treatment- related undesirable effects)
Evaluating the safety of nitazoxanide by estimation of treatment- related undesirable effects
Measured: 37 days
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Principal investigator, Asmaa Abdel Aziz ElRakaybi, Ain Shams University
- Investigators
- Asmaa A. Elrakaybi, Bachelor, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334163
- Sponsor's protocol ID
- PHCL400
- Status last verified
- Jan 2015
- First submitted
- 6 Jan 2015
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effects of Nitazoxanide in Hepatic Encephalopathy Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT02334163
- Acronym / sponsor ID
- PHCL400
- Conditions
- Hepatic Encephalopathy
- Keywords
- Hepatic Encephalopathy, Nitazoxanide, Serum ammonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- Dec 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide group | Experimental | Drug: Nitazoxanide, Drug: Oral lactulose12 patients will receive the following for 7 days: * Oral lactulose * 500 mg nitazoxanide tablets twice daily |
| Metronidazole group | Active comparator | Drug: Oral lactulose, Drug: Metronidazole12 patients will receive the following for 7 days: * Oral lactulose * 250 mg metronidazole tablets every 8 hours |
| Rifaximine group | Active comparator | Drug: Oral lactulose, Drug: Rifaximine12 patients will receive the following for 7 days: * Oral lactulose * Two 200 mg rifaximine tablets every 8 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult Patients from 18 to 65 years.
- Patients with grade II-III Hepatic Encephalopathy.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitazoxanide500 mg nitazoxanide tablets twice daily | Drug | Nitazoxanide group |
| Oral lactuloseOral lactulose (65%) | Drug | Metronidazole group, Nitazoxanide group, Rifaximine group |
| Metronidazole250 mg metronidazole tablets every 8 hours | Drug | Metronidazole group |
| RifaximineTwo 200 mg rifaximine tablets every 8 hours | Drug | Rifaximine group |
Primary outcome
Evaluating the efficacy of nitazoxanide in improving mental status (calculating CHESS score)
Time frame: 7 days
evaluating the efficacy by measuring serum ammonia and calculating CHESS score at baseline and at end of treatment
2 secondary outcomes
Evaluating the safety of nitazoxanide (estimation of treatment- related undesirable effects)
Time frame: 37 days
Effect of nitazoxanide on patient's quality of life (CLDQ score)
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal T. Abd ElMoez, PhD contact
Asmaa A. Elrakaybi, Bachelor principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitazoxanide, Oral lactulose and Metronidazole in people with Hepatic Encephalopathy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amal T. Abd ElMoez, PhD (d_amal_tohamy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the efficacy of nitazoxanide in improving mental status (calculating CHESS score) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2015.