A Phase 2/3 interventional study of Rifaximin + propranolol and Propranolol + Placebo in Liver Cirrhosis and Portal Hypertension, sponsored by Yonsei University. Status unknown at 2 sites in South Korea. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-04-21.
Sponsored by Yonsei University · Phase 2/3, Interventional, and Treatment
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.
1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.
This study's planned enrollment of 140 is above the median of 72 across 1,003 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Rifaximin(normix®)+nonselective beta-blocker(Propranolol)
Drug: Rifaximin + propranolol
nonselective beta-blocker(Propranolol) + Placebo(of Rifaximin)
Drug: Propranolol + Placebo
Drug pages: Rifaximin · Propranolol
1. Rifaximin : taking 400mg three times a day in the study period (total 1,200 mg per day) 2. Propranolol : taking 40mg twice a day to start. If patient is tolerable and systolic blood pressure is above 90 mmHg, the dosage can be increased by doubling to every other day upto the 360mg per day. (Target heart rate : 25% reduction in baseline heart rate or at least 55 times per minute). If patient is not tolerable, we can reduce the dosage step-by-step until the adverse symptoms is disappeared.
Also known as: Normix, Propranolol
1. Placebo of Rifaximin : taking 400mg three times a day in the study period (total 1,200 mg per day) 2. Propranolol : taking 40mg twice a day to start. If patient is tolerable and systolic blood pressure is above 90 mmHg, the dosage can be increased by doubling to every other day upto the 360mg per day. (Target heart rate : 25% reduction in baseline heart rate or at least 55 times per minute). If patient is not tolerable, we can reduce the dosage step-by-step until the adverse symptoms is disappeared.
Also known as: Non-selective beta-blocker, Placebo of Rifaximin
Hepatic vein pressure gradient(HVPG)
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
Time frame: Change from baseline heptic vein pressure gradient at 6 weeks
occurence of gastrointestinal bleeding
when gastrointestinal bleeding occurs, after initiation of treatment, endoscopy will be performed to evaluate status of bleeding
Time frame: upto 6 months after initiation of treatment
This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Rifaximin · Propranolol