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RNHE2041: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)

Clinical Trial Details

This clinical trial is to evaluate an experimental (investigational) drug in men or women with overt hepatic encephalopathy (OHE). Hepatic encephalopathy is a major complication of cirrhosis and the result is liver cell death. Liver cell death results in inflammation and fibrosis (scarring) of the liver. 

This study is being done to determine if the new investigational (study drug) modified forms of rifaximin (called rifaximin SSD) are safe and effective for treating OHE. 

All eligible participants in this study will be randomized (by chance) into one of the following study drug groups: 

  • Group 1 – Participants will receive 40mg immediate release (IR) rifaximin SSD tablet once daily and lactulose. 
  • Group 2 – Participants will receive 40mg immediate release (IR) rifaximin SSD tablet twice daily and lactulose. 
  • Group 3 - Participants will receive 80mg immediate release (IR) rifaximin SSD tablet once daily and lactulose. 
  • Group 4 – Participants will receive 80mg immediate release (IR) rifaximin SSD tablet twice daily and lactulose. 
  • Group 5 – Participants will receive placebo tablet twice daily and lactulose. 

Rifaximin (Xifaxan®) is currently Food and Drug Administration (FDA) approved at a dose of 550 mg taken twice a day to reduce the risk of recurrent episodes of a condition called overt hepatic encephalopathy (OHE), which may occur in people with liver cirrhosis. 

The “investigational” part of the study is that new modified forms of the current version of rifaximin are being used. The different forms of the drug being tested are also designed to deliver most of the main ingredient in the pill to specifically targeted areas of the gut, this may allow for the use of a lower total amount of the drug to treat the disease. 

A placebo looks like the active study drug and is given in the same way but has no real medicine in it. 

Participants will take the study drug for up to 14 days while in the hospital. After hospital discharge, three clinic visits will be scheduled. These visits will be about 7, 14, and 30 days after hospital discharge. Study participants will be compensated for their time. 

Key Eligibility: 
  • Men and women who are 18 years of age and older. 
  • Diagnosed with overt hepatic encephalopathy (OHE) 
  • Detailed eligibility reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1807019450

ClinicalTrials.gov:

NCT03515044

Sponsor:

RNHE2041

Status

Open to Enrollment

Age Group

Adult

Sponsor