Covert Hepatic EncephalopathyPhase 4NCT03077217
Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy
A Phase 4 study testing Rifaximin in people with Covert Hepatic Encephalopathy, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
Several studies have been showed that rifaximin can improve cognitive functions, driving simulator performance and health-related quality of life in patients with minimal hepatic encephalopathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Covert Hepatic Encephalopathy
- What is being tested?
- Rifaximin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 31 May 2020
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients agreed to sign the informed consents
- Patients aged 18-70 years，males or females
- Patients who were diagnosed with occult hepatic encephalopathy by PHES and Stroop tests
Who cannot join
- Allergy to rifamycin/rifamutin/rifampin/rifapentine
- Current or recent (<3 month) use of alcohol or can't stop drinking during the study period
- Use of antibiotics within last 6 weeks
- Use of lactulose/lactitol, probiotics, L-ornithine-L-aspart，zinc，metronidazole, neomycin, or rifaximin within last 6 weeks
- Infection or gastrointestinal hemorrhage within last 6 weeks
- Use of psychoactive drugs within last 6 weeks
Show all 17Show fewer
- Occurred overt hepatic encephalopathy within last 3 months
- history of portosystemic shunt surgery or transjugular intrahepatic portosystemic shunt
- Poor vision, color blindness or motor defects that interfere with the performance of psychometric tests
- Other non-controllable neurological or psychiatric problems which may affect cognitive function such as Alzheimer's disease, Parkinson's disease or schizophrenia
- Conformed or highly suspicious diagnosis of liver malignant tumors
- Human immunodeficiency virus (HIV) infection
- Uncontrolled hypertension, diabetes or other serious cardiac and pulmonary diseases
- White blood cell count<1×10^9/L
- Pregnancy and breastfeeding
- Participated in other drug clinical trials within 3 months
- The researchers thought it was not suitable for this clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai changzheng Hospital
Shanghai, Shanghai Municipality, 200003
About this study
Official title: Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy: A Randomized Open Controlled Study
Several studies have been showed that rifaximin can improve cognitive functions, driving simulator performance and health-related quality of life in patients with minimal hepatic encephalopathy. The aim of this prospective randomized open controlled study was to evaluate the efficacy and safety of rifaximin at different doses for the treatment of covert hepatic encephalopathy.
- Conditions
- Covert Hepatic Encephalopathy
- Being tested
- Rifaximin
- Keywords
- covert hepatic encephalopathy, low-dose rifaximin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy
| Study group | Role | What they receive |
|---|---|---|
| the high-dose rifaximin | Active comparator | The high-dose rifaximin group was given rifaximin 1200 mg/day for 8 weeks. Receives: Drug: Rifaximin |
| the low-dose rifaximinl group | Active comparator | The low-dose rifaximin group was given rifaximin 800 mg/day for 8 weeks. Receives: Drug: Rifaximin |
| the control group | Placebo comparator | The control group didn't receive rifaximin treatment Receives: Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients showing covert hepatic encephalopathy reversal
the percentage of patients showing covert hepatic encephalopathy reversal
Measured: up to 6 months
health-related quality of life improvement
complete the questionnaire "sickness impact profile"
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 May 2017
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covert Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Fen Xie, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077217
- Sponsor's protocol ID
- CZH0010
- Status last verified
- Jun 2021
- First submitted
- 30 Jan 2017
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
PubMed 37467180
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy: A Randomized Open Controlled Study
- ClinicalTrials.gov ID
- NCT03077217
- Acronym / sponsor ID
- CZH0010
- Conditions
- Covert Hepatic Encephalopathy
- Keywords
- covert hepatic encephalopathy, low-dose rifaximin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 10 Mar 2017 (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.
Several studies have been showed that rifaximin can improve cognitive functions, driving simulator performance and health-related quality of life in patients with minimal hepatic encephalopathy. The aim of this prospective randomized open controlled study was to evaluate the efficacy and safety of rifaximin at different doses for the treatment of covert hepatic encephalopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the high-dose rifaximin | Active comparator | Drug: RifaximinThe high-dose rifaximin group was given rifaximin 1200 mg/day for 8 weeks. |
| the low-dose rifaximinl group | Active comparator | Drug: RifaximinThe low-dose rifaximin group was given rifaximin 800 mg/day for 8 weeks. |
| the control group | Placebo comparator | Drug: RifaximinThe control group didn't receive rifaximin treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients agreed to sign the informed consents
- Patients aged 18-70 years，males or females
- Patients who were diagnosed with occult hepatic encephalopathy by PHES and Stroop tests
Key exclusion criteria (17 listed)
- Allergy to rifamycin/rifamutin/rifampin/rifapentine
- Current or recent (<3 month) use of alcohol or can't stop drinking during the study period
- Use of antibiotics within last 6 weeks
- Use of lactulose/lactitol, probiotics, L-ornithine-L-aspart，zinc，metronidazole, neomycin, or rifaximin within last 6 weeks
- Infection or gastrointestinal hemorrhage within last 6 weeks
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 |
|---|---|---|
| RifaximinThe investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy | Drug | the control group, the high-dose rifaximin, the low-dose rifaximinl group |
Primary outcome
Percentage of patients showing covert hepatic encephalopathy reversal
Time frame: up to 6 months
the percentage of patients showing covert hepatic encephalopathy reversal
health-related quality of life improvement
Time frame: up to 6 month
complete the questionnaire "sickness impact profile"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Derived from this study: PubMed 37467180Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
- Individual participant dataSharing planned: No
Related trials for Covert Hepatic Encephalopathy
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifaximin in people with Covert Hepatic Encephalopathy, run by Shanghai Changzheng Hospital at 1 site in China.
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 3 inclusion and 17 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: finished, as of the sponsor's last update on 1 Jul 2021. 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 China. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients showing covert hepatic encephalopathy reversal (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03077217, which also lists 1 linked publication.
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 1 Jul 2021.