Rifaximin and Propranolol Combination Therapy Versus Propranolol Monotherapy in Cirrhotic Patients

Phase 2

• Conditions: Portal Hypertension; Liver Cirrhosis
• Interventions: Drug: Propranolol + Placebo; Drug: Rifaximin + propranolol

• Registration Number: NCT01897051
• Lead Sponsor: Yonsei University

Brief Summary

To reduce portal pressure, the only recommended medication is nonselective beta blocker(NSBB). However, NSBB has some limitation to apply clinically because of poor response rate and compliance.

Recent literature has supported the role of bacterial translocation as a mediator of splanchnic vasodilatation and portal hypertension. This stimulates the release of pro-inflammatory cytokines and the activation of the vasodilator NO resulting in a more pronounced deterioration of the baseline hyperdynamic circulatory state. Selective gut decontamination with Rifaximin can induce inhibition of bacterial translocation and associated worsening of portal hypertension. The investigators hypothesized that Rifaximin plus NSBB could result in decrease of portal pressure in cirrhotic patients with esophageal varices.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-08
• Study First Posted: 2013-07-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-19
• Last Update Posted: 2015-04-21
• Primary Completion: 2017-02
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Liver cirrhosis:diagnosed based on histology or unequivocal clinical, sonographic, and laboratory findings
• 19≤age≤75
• Hepatic venous pressure gradient > 12 mmHg
• Informed consent

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Exclusion Criteria

• Shock status requiring vasopressor
• Active infection, for example Spontaneous bacterial peritonitis
• Acute renal failure patients of any cause
• Clinically relevant coronary artery disease(NYHA functional angina classification III/IV),congestive heart failure NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the past 12 months
• Poorly controlled hypertension (BP 150/100mmHg)
• Hepatocellular carcinoma
• History of another primary malignancy ≤ 3years
• Medical or psychological conditions that would not permit the subject to complete thte study or sign informed consent
• Pregnancy or lactation period
• Serum creatinine ≧ 6mg/dL
• Involvement in the conduct of other study within 30 days
• Known hypersensitivity to Rifaximin or propranolol
• Dysarrhythmia, inappropriate for study on investigator's judgment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monotherapy	Propranolol + Placebo	nonselective beta-blocker(Propranolol) + Placebo(of Rifaximin)
Combination therapy	Rifaximin + propranolol	Rifaximin(normix®)+nonselective beta-blocker(Propranolol)

Primary Outcome Measures

Name	Time	Method
Hepatic vein pressure gradient(HVPG)	Change from baseline heptic vein pressure gradient at 6 weeks	After measurement of baseline HVPG, patients will be randomized to treatment group of Rifaximin + Propranolol or Propranolol + Placebo. And 6 weeks after treatment, follow-up measurement of HVPG will be performed to evaluate efficacy of two regimens

Secondary Outcome Measures

Name	Time	Method
occurence of gastrointestinal bleeding	upto 6 months after initiation of treatment	when gastrointestinal bleeding occurs, after initiation of treatment, endoscopy will be performed to evaluate status of bleeding

Trial Locations

Locations (2)

Yonsei University Wonju Severance Cristian Hospital; 🇰🇷 Wonju, Kangwon-do, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Korea, Republic of