Status:
UNKNOWN
Rifaximin and Propranolol Combination Therapy Versus Propranolol Monotherapy in Cirrhotic Patients
Lead Sponsor:
Yonsei University
Conditions:
Liver Cirrhosis
Portal Hypertension
Eligibility:
All Genders
19-75 years
Phase:
PHASE2
PHASE3
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. Rece...
Eligibility Criteria
Inclusion
- Liver cirrhosis:diagnosed based on histology or unequivocal clinical, sonographic, and laboratory findings
- 19≤age≤75
- Hepatic venous pressure gradient \> 12 mmHg
- Informed consent
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2017
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01897051
Start Date
July 1 2013
End Date
June 1 2017
Last Update
April 21 2015
Active Locations (2)
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1
Yonsei University Wonju Severance Cristian Hospital
Wŏnju, Gangwon-do, South Korea, 220-701
2
Wonju Severance Christian Hospital
Wŏnju, South Korea