Decompensated CirrhosisRPPCLCNCT05863364
Rifaximin for Preventing Progression and Complications in Patients With Decompensated Liver Cirrhosis
A study testing Low-dose of Rifaximin and Conventional dose of Rifaximin in people with Decompensated Cirrhosis, run by Xin Zeng at 1 site in China.
Trial summary
It is still not clear whether rifaximin can prevent the progression of liver cirrhosis, reduce the overall complications and improve the survival in patients with decompensated cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Decompensated Cirrhosis
- What is being tested?
- Low-dose of Rifaximin and Conventional dose of Rifaximin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2023to 31 Dec 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With a clinical diagnosis of decompensated liver cirrhosis on the basis of typical clinical manifestations, laboratory tests, imaging appearances and/or representative pathology results of liver biopsy. Decompensation of the disease was defined by at least having an episode of severe complications, including ascites, SBP, EGVB and HE.
Who cannot join
- Episodes of overt HE, EGVB or SBP within 4 weeks before the screening visit
- Uncontrolled severe infection or antibiotic use within 2 weeks before the screening visit
- Hepatitis B virus (HBV) DNA ≥ 500 copy/mL，or receipt of standard antiviral treatment for hepatitis B for less than 12 months
- Receiving antiviral treatment for hepatitis C or receipt of antiviral treatment for hepatitis C within 12 months before the screening visit
- If patients with autoimmune liver disease have been treated with ursodeoxycholic acid, hormone or other immunosuppressants, the dose stability time is less than 6 months
- With history of alcoholism in the last 12 weeks or unwilling to stop alcohol abuse after inclusion (≥ 20 g/day for women or ≥ 30 g/day for men)
Show all 17Show fewer
- With confirmed or suspected malignancies
- Severe jaundice (serum total bilirubin level ≥ 85 μmol/L)
- Obvious renal dysfunction (serum creatinine ≥ 1.2-fold of upper normal limits)
- Severe electrolyte abnormality (serum sodium level < 125 mmol/L )
- Life-threatening leucocytopenia (white blood cell count < 1 × 10^9/L )
- Poorly controlled hypertension, diabetes mellitus or other severe heart and respiratory diseases (NYHA Ⅲ/Ⅳ, COPD GOLD C)
- With drug abuse, methadone treatment, drug dependence or mental illness
- HIV seropositivity
- Known to be allergic to rifaximin
- Pregnant and lactating women or women who do not rule out pregnancy
- Those who have participated in other drug trials within 12 weeks
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, 200120
Wen-Na Li, Dr., 086018661803012, zengxinmd1978@163.com
About this study
Official title: Rifaximin for Preventing Progression and Complications in Patients With Decompensated Liver Cirrhosis: a Multi-center Randomized Prospective Study
It is still not clear whether rifaximin can prevent the progression of liver cirrhosis, reduce the overall complications and improve the survival in patients with decompensated cirrhosis. This is a multi-center open-labelled randomized prospective study to evaluate the efficacy and safety of rifaximin in preventing the progression and complications in cirrhotic patients, and explore its reasonable dosage and possible mechanism. A total of 150 patients with decompensated liver cirrhosis will be enrolled in the study and randomly divided into three groups (the control group (A), the low-dose rifaximin treatment group (B), and conventional dose rifaximin treatment group (C)) with a ratio of 1:2:2. The patients in group B are given rifaximin with the dose of 600mg/d (600mg, qd) for 24 weeks, and the patients in group C are delivered 1200mg/d (600mg, bid) of rifaximin .During the entire study period, all other therapeutic strategies are kept unchanged in all the groups as long as possible. The proportion of patients with progression of cirrhosis, the incidence of total complications and each complication, survival rate and time, liver function and adverse events will be compared among the three groups. This study might provide a new feasible method with clinical application prospects for preventing the progression and reducing the incidence of liver cirrhosis related complications, improve the prognosis of patients with decompensated liver cirrhosis, and save medical resources.
Read the detailed description
Rifaximin has been recommended as a prophylactic drug for hepatic encephalopathy (HE) and spontaneous bacterial peritonitis (SBP), the two major complications of liver cirrhosis. However, it is still not clear whether rifaximin can prevent the progression of liver cirrhosis, reduce the overall complications and improve the survival in patients with decompensated cirrhosis. Additionally, the role of rifaximin in the treatment of liver cirrhosis has not been fully clarified. We designed a multi-center open-labelled randomized prospective study to evaluate the efficacy and safety of rifaximin in preventing the progression and complications in cirrhotic patients, and explore its reasonable dosage and possible mechanism. A total of 150 patients with decompensated liver cirrhosis will be enrolled in the study. They will be randomly divided into three groups (the control group (A), the low-dose rifaximin treatment group (B), and conventional dose rifaximin treatment group (C)) with a ratio of 1:2:2. The patients in group B are given rifaximin with the dose of 600mg/d (600mg, qd) for 24 weeks, and the patients in group C are delivered 1200mg/d (600mg, bid) of rifaximin .During the entire study period, all other therapeutic strategies, such as antiviral agents, non-selective beta-blockers, liver protectants, and diuretics, are kept unchanged in all the groups as long as possible. The proportion of patients with progression of cirrhosis, acute decompensation, acute-on-chronic liver failure (ACLF), decompensation and stable decompensated cirrhosis, the incidence of total complications and each complication, survival rate and time, liver function and adverse events will be compared among the three groups. This study might provide a new feasible method with clinical application prospects for preventing the progression and reducing the incidence of liver cirrhosis related complications, improve the prognosis of patients with decompensated liver cirrhosis, and save medical resources.
- Conditions
- Decompensated Cirrhosis
- Being tested
- Low-dose of Rifaximin, Conventional dose of Rifaximin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose of RifaximinDrug
Also called Low-dose of Xifaxan
The patients in group B were given rifaximin with the dose of 600mg/d (600mg, qd) for 24 weeks
Conventional dose of RifaximinDrug
Also called Conventional dose of Xifaxan
the patients in group C were delivered 1200mg/d (600mg, bid) for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Group A: Patients in the control group were administered only conventional therapy |
| the low-dose rifaximin treatment group | Experimental | Group B Receives: Drug: Low-dose of Rifaximin |
| the conventional dose rifaximin treatment group | Experimental | Group C Receives: Drug: Conventional dose of Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with progression of liver cirrhosis
The proportion of patients with progression of liver cirrhosis, which is defined as at least one additional stage of liver cirrhosis staging during the 24-week treatment phase
Measured: 24 weeks
Secondary outcomes (12)
Incidence of overall complications resulting from decompensated liver cirrhosis
The incidence of overall complications resulting from decompensated liver cirrhosis in 12weeks and 24weeks, including refractory ascites, SBP, esophageal and gastric variceal bleeding (EGVB), overt hepatic encephalopathy(OHE), cute renal injury (AKI)/hepatorenal syndrome (HRS), primary hepatic carcinoma (PHC), etc.
Measured: 12 and 24weeks
Incidence of various complications of liver cirrhosis, including: refractory ascites, SBP, EGVB, OHE, AKI/HRS, PHC, etc.
The incidence of each complication resulting from decompensated liver cirrhosis in 12weeks and 24weeks, including refractory ascites, SBP, EGVB, OHE, AKI/HRS, PHC, etc.
Measured: 12 weeks and 24 weeks
The proportion of patients with progression of liver cirrhosis
The proportion of patients with progression of liver cirrhosis, which is defined as at least one additional stage of liver cirrhosis staging during the 12-week treatment phase
Measured: 12 weeks
The proportion of patients with acute decompensated (AD)
The proportion of patients with acute decompensated (AD)
Measured: 12 and 24 weeks
The proportion of patients with stable decompensated cirrhosis
The proportion of patients with stable decompensated cirrhosis, which is defined as patients with decompensated cirrhosis who, while receiving sustained prophylaxis with diuretics, and/or lactulose or rifaximin, and/or non-selective beta-blockers or repeated endoscopic treatment of esophagogastric varices, do not present episodes of AD for a long-time period.
Measured: 24 weeks
The proportion of patients with recompensation of cirrhosis
The proportion of patients with recompensation of cirrhosis, which is defined as the clinical phase of the disease prior to the resolution of cirrhosis induced by successful treatment of the underlying aetiology.
Measured: 24 weeks
All-cause mortality
All-cause mortality during the 24-week treatment phase
Measured: 24 weeks
Complication-free survival time
Complication-free survival time during the treatment phase
Measured: 24 weeks
Liver transplantation free survival time
Liver transplantation free survival time during the treatment phase
Measured: 24 weeks
Child-Pugh score
Liver function reflected by Child-Pugh score. A higher Child-Pugh score mean a worse outcome
Measured: 24 weeks
The proportion of patients with different Child-Pugh class
The proportion of patients with Child-Pugh A/B/C （Child-Pugh A: Child-Pugh score<7; Child-Pugh B: Child-Pugh score 7~9; Child-Pugh C: Child-Pugh score>9 ）
Measured: 24 weeks
Model for end-stage liver disease (MELD) score
Liver function reflected by MELD score. A higher MELD score mean a worse outcome
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start18 Aug 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated CirrhosisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xin Zeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Zeng, Shanghai East Hospital
- Investigators
- Xin Zeng, Dr., Principal investigator, Department of Gastroenterology, Shanghai East Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863364
- Sponsor's protocol ID
- DFYY2022096
- Acronym
- RPPCLC
- Status last verified
- May 2023
- First submitted
- 28 Dec 2022
- Last updated
- 8 Aug 2023
- Results posted
- No
- 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 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifaximin for Preventing Progression and Complications in Patients With Decompensated Liver Cirrhosis: a Multi-center Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT05863364
- Acronym / sponsor ID
- RPPCLC / DFYY2022096
- Conditions
- Decompensated Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xin ZengUniversity, hospital or other
- Study start
- 18 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 May 2023 (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.
It is still not clear whether rifaximin can prevent the progression of liver cirrhosis, reduce the overall complications and improve the survival in patients with decompensated cirrhosis. This is a multi-center open-labelled randomized prospective study to evaluate the efficacy and safety of rifaximin in preventing the progression and complications in cirrhotic patients, and explore its reasonable dosage and possible mechanism. A total of 150 patients with decompensated liver cirrhosis will be enrolled in the study and randomly divided into three groups (the control group (A), the low-dose rifaximin treatment group (B), and conventional dose rifaximin treatment group (C)) with a ratio of 1:2:2. The patients in group B are given rifaximin with the dose of 600mg/d (600mg, qd) for 24 weeks, and the patients in group C are delivered 1200mg/d (600mg, bid) of rifaximin .During the entire study period, all other therapeutic strategies are kept unchanged in all the groups as long as possible. The proportion of patients with progression of cirrhosis, the incidence of total complications and each complication, survival rate and time, liver function and adverse events will be compared among the three groups. This study might provide a new feasible method with clinical application prospects for preventing the progression and reducing the incidence of liver cirrhosis related complications, improve the prognosis of patients with decompensated liver cirrhosis, and save medical resources.
Detailed description
Rifaximin has been recommended as a prophylactic drug for hepatic encephalopathy (HE) and spontaneous bacterial peritonitis (SBP), the two major complications of liver cirrhosis. However, it is still not clear whether rifaximin can prevent the progression of liver cirrhosis, reduce the overall complications and improve the survival in patients with decompensated cirrhosis. Additionally, the role of rifaximin in the treatment of liver cirrhosis has not been fully clarified. We designed a multi-center open-labelled randomized prospective study to evaluate the efficacy and safety of rifaximin in preventing the progression and complications in cirrhotic patients, and explore its reasonable dosage and possible mechanism. A total of 150 patients with decompensated liver cirrhosis will be enrolled in the study. They will be randomly divided into three groups (the control group (A), the low-dose rifaximin treatment group (B), and conventional dose rifaximin treatment group (C)) with a ratio of 1:2:2. The patients in group B are given rifaximin with the dose of 600mg/d (600mg, qd) for 24 weeks, and the patients in group C are delivered 1200mg/d (600mg, bid) of rifaximin .During the entire study period, all other therapeutic strategies, such as antiviral agents, non-selective beta-blockers, liver protectants, and diuretics, are kept unchanged in all the groups as long as possible. The proportion of patients with progression of cirrhosis, acute decompensation, acute-on-chronic liver failure (ACLF), decompensation and stable decompensated cirrhosis, the incidence of total complications and each complication, survival rate and time, liver function and adverse events will be compared among the three groups. This study might provide a new feasible method with clinical application prospects for preventing the progression and reducing the incidence of liver cirrhosis related complications, improve the prognosis of patients with decompensated liver cirrhosis, and save medical resources.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Group A: Patients in the control group were administered only conventional therapy |
| the low-dose rifaximin treatment group | Experimental | Drug: Low-dose of RifaximinGroup B |
| the conventional dose rifaximin treatment group | Experimental | Drug: Conventional dose of RifaximinGroup C |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- With a clinical diagnosis of decompensated liver cirrhosis on the basis of typical clinical manifestations, laboratory tests, imaging appearances and/or representative pathology results of liver biopsy. Decompensation of the disease was defined by at least having an episode of severe complications, including ascites, SBP, EGVB and HE.
Key exclusion criteria (17 listed)
- Episodes of overt HE, EGVB or SBP within 4 weeks before the screening visit
- Uncontrolled severe infection or antibiotic use within 2 weeks before the screening visit
- Hepatitis B virus (HBV) DNA ≥ 500 copy/mL，or receipt of standard antiviral treatment for hepatitis B for less than 12 months
- Receiving antiviral treatment for hepatitis C or receipt of antiviral treatment for hepatitis C within 12 months before the screening visit
- If patients with autoimmune liver disease have been treated with ursodeoxycholic acid, hormone or other immunosuppressants, the dose stability time is less than 6 months
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 |
|---|---|---|
| Low-dose of RifaximinAlso: Low-dose of XifaxanThe patients in group B were given rifaximin with the dose of 600mg/d (600mg, qd) for 24 weeks | Drug | the low-dose rifaximin treatment group |
| Conventional dose of RifaximinAlso: Conventional dose of Xifaxanthe patients in group C were delivered 1200mg/d (600mg, bid) for 24 weeks | Drug | the conventional dose rifaximin treatment group |
Primary outcome
The proportion of patients with progression of liver cirrhosis
Time frame: 24 weeks
The proportion of patients with progression of liver cirrhosis, which is defined as at least one additional stage of liver cirrhosis staging during the 24-week treatment phase
12 secondary outcomes
Incidence of overall complications resulting from decompensated liver cirrhosis
Time frame: 12 and 24weeks
Incidence of various complications of liver cirrhosis, including: refractory ascites, SBP, EGVB, OHE, AKI/HRS, PHC, etc.
Time frame: 12 weeks and 24 weeks
The proportion of patients with progression of liver cirrhosis
Time frame: 12 weeks
The proportion of patients with acute decompensated (AD)
Time frame: 12 and 24 weeks
The proportion of patients with stable decompensated cirrhosis
Time frame: 24 weeks
The proportion of patients with recompensation of cirrhosis
Time frame: 24 weeks
All-cause mortality
Time frame: 24 weeks
Complication-free survival time
Time frame: 24 weeks
Liver transplantation free survival time
Time frame: 24 weeks
Child-Pugh score
Time frame: 24 weeks
The proportion of patients with different Child-Pugh class
Time frame: 24 weeks
Model for end-stage liver disease (MELD) score
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- 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. This study is not recruiting at the moment.
Xin Zeng, Dr. principal investigator
Department of Gastroenterology, Shanghai East Hospital, Tongji University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose of Rifaximin and Conventional dose of Rifaximin in people with Decompensated Cirrhosis, run by Xin Zeng 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 1 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: status not confirmed, as of the sponsor's last update on 8 Aug 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Xin Zeng, Dr. (086018918353309, zengxinmd1978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with progression of liver cirrhosis (time frame: 24 weeks). 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 Aug 2023.