Hepatic EncephalopathyPhase 3NCT04161053
Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy
A Phase 3 study testing Rifaximin and Nitazoxanide in people with Hepatic Encephalopathy, run by Tanta University at 1 site in Egypt.
Trial summary
Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- Rifaximin and Nitazoxanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic patient with at least one previous episode of hepatic encephalopathy.
- Adult Patients aging from 20 to 65 years old
Who cannot join
- Active GIT bleeding.
- Major psychiatric illness (psychosis \& epilepsy).
- Renal insufficiency (S.Cr 2mg/dl).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-Elsalam
About this study
Official title: Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy
Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.
Read the detailed description
Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.
- Conditions
- Hepatic Encephalopathy
- Being tested
- Rifaximin, Nitazoxanide
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called Gastrobiotic, Trencedia
Rifaximin 550 mg twice daily for 6 months
NitazoxanideDrug
Also called Nanazoxid
Nitazoxanide 500 mg twice daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin | Active comparator | 550 mg Rifaximin tablets twice daily for six months. Receives: Drug: Rifaximin |
| Nitazoxanide | Experimental | 500 mg Nitazoxanide tablets twice daily for six months. Receives: Drug: Nitazoxanide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of encephalopathy episodes during treatment
The number of encephalopathy episodes during treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Nov 2018
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (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 Tanta 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Khadija Ahmed Glal, Msc, Principal investigator, Tanta UniversityTarek Mohamed Mostafa, ass, Prof., Principal investigator, Tanta UniversitySherief Abd-Elsalam, Ass. Prof., Principal investigator, Tanta University - Tropical Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161053
- Sponsor's protocol ID
- Encephalopathy
- Status last verified
- Nov 2019
- First submitted
- 8 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT04161053
- Acronym / sponsor ID
- Encephalopathy
- Conditions
- Hepatic Encephalopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Nov 2019 (actual)
- 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.
Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.
Detailed description
Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin | Active comparator | Drug: Rifaximin550 mg Rifaximin tablets twice daily for six months. |
| Nitazoxanide | Experimental | Drug: Nitazoxanide500 mg Nitazoxanide tablets twice daily for six months. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cirrhotic patient with at least one previous episode of hepatic encephalopathy.
- Adult Patients aging from 20 to 65 years old
Key exclusion criteria (3 listed)
- Active GIT bleeding.
- Major psychiatric illness (psychosis \& epilepsy).
- Renal insufficiency (S.Cr 2mg/dl).
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 |
|---|---|---|
| RifaximinAlso: Gastrobiotic, TrencediaRifaximin 550 mg twice daily for 6 months | Drug | Rifaximin |
| NitazoxanideAlso: NanazoxidNitazoxanide 500 mg twice daily for 6 months | Drug | Nitazoxanide |
Primary outcome
Number of encephalopathy episodes during treatment
Time frame: 6 months
The number of encephalopathy episodes during treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Khadija Ahmed Glal, Msc principal investigator
Tanta University
Tarek Mohamed Mostafa, ass, Prof. principal investigator
Tanta University
Sherief Abd-Elsalam, Ass. Prof. principal investigator
Tanta University - Tropical Medicine Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rifaximin and Nitazoxanide in people with Hepatic Encephalopathy, run by Tanta 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 3 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: looking for participants now, as of the sponsor's last update on 13 Nov 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of encephalopathy episodes during treatment (time frame: 6 months). 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 13 Nov 2019.