Rifaximin for Preventing Progression and Complications in Patients With Decompensated Liver Cirrhosis

NCT05863364 | Unknown

• 1 other identifier: DFYY2022096
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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

  24 weeks

Secondary Outcomes (12)

• Incidence of overall complications resulting from decompensated liver cirrhosis

  12 and 24weeks

• Incidence of various complications of liver cirrhosis, including: refractory ascites, SBP, EGVB, OHE, AKI/HRS, PHC, etc.

  12 weeks and 24 weeks

• The proportion of patients with progression of liver cirrhosis

  12 weeks

• The proportion of patients with acute decompensated (AD)

  12 and 24 weeks

• The proportion of patients with stable decompensated cirrhosis

  24 weeks

Other Outcomes (4)

• Incidence of ACLF

  24 weeks

• Health-related quality of life (HRQoL)

  24 weeks

• Sarcopenia

  24 weeks

Study Arms (3)

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

Drug: Low-dose of Rifaximin

the conventional dose rifaximin treatment group

EXPERIMENTAL

Group C

Drug: Conventional dose of Rifaximin

Interventions

Low-dose of Rifaximin DRUG

The patients in group B were given rifaximin with the dose of 600mg/d (600mg, qd) for 24 weeks

Also known as: Low-dose of Xifaxan

the low-dose rifaximin treatment group

Conventional dose of Rifaximin DRUG

the patients in group C were delivered 1200mg/d (600mg, bid) for 24 weeks

Also known as: Conventional dose of Xifaxan

the conventional dose rifaximin treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Xin Zeng: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, 200120, China

RECRUITING

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Xin Zeng, Dr.

  Department of Gastroenterology, Shanghai East Hospital, Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Zeng, Dr.

CONTACT

086018918353309; zengxinmd1978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the department of gastroenterology

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: May 18, 2023
• Study Start: August 18, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)