Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05863364
Status:
RECRUITING
Last Update Posted:
2023-08-08
First Post:
2022-12-28
Brief Title:
Rifaximin for Preventing Progression and Complications in Patients With Decompensated Liver Cirrhosis
Sponsor:
Xin Zeng
Organization:
Shanghai East Hospital
Study Overview
Official Title:
Rifaximin for Preventing Progression and Complications in Patients With Decompensated Liver Cirrhosis a Multi-center Randomized Prospective Study
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RPPCLC
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 122 The patients in group B are given rifaximin with the dose of 600mgd 600mg qd for 24 weeks and the patients in group C are delivered 1200mgd 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 122 The patients in group B are given rifaximin with the dose of 600mgd 600mg qd for 24 weeks and the patients in group C are delivered 1200mgd 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None