RNLC3132
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Efficacy And Safety Of Rifaximin Soluble Solid Dispersion (Ssd) Tablets For The Delay Of Encephalopathy Decompensation In Cirrhosis (Red-C)
IRAS ID
1007692
Contact name
John Lahey
Contact email
Sponsor organisation
Salix Pharmaceuticals, Inc. an affiliate of Bausch Health US, LLC
Eudract number
2022-502899-23
Research summary
The purpose of this clinical research study is to see if the study drug named Rifaximin SSD-40IR will help to delay the first time a patient over the age of 18 with liver cirrhosis needs to be hospitalised due to overt hepatic encephalopathy (HE). HE is a nervous system disorder caused by a build-up of toxins such as ammonia in the blood when the liver does not work properly. Overt means that the symptoms of hepatic encephalopathy are obvious. The study will also look at how safe the study drug is when used for 72 weeks. This study is a randomised study, with one group of patients receiving the study drug while a second ‘control’ group receive a placebo (dummy pill). Neither the patient nor the study doctor will know if they are receiving the study drug or a placebo.
Patient participation in the study will last about 80 weeks, which will consist of 14 visits to the study centre and 7 phone calls for tests and assessments to check their health, symptoms and any side effects they may be experiencing. During the study treatment period, patients will be asked to take the study medication at home, twice a day, 12 hours apart and at around the same time each day.
Rifaximin is an antibiotic. Antibiotics can be used to reduce the amount of ammonia and other toxins in the blood that are produced by bacteria. It is approved by the health authority in the UK to be used as a treatment to help prevent HE in people with liver cirrhosis who have already had an episode of HE. It is not approved to help prevent HE in people with liver cirrhosis who have not had HE before.
The currently marketed drug containing rifaximin is a tablet that is dissolved by bile acids. Bile is a liquid made in the liver and released into the intestines (bowels) to help digestion. The sponsor has developed a soluble solid dispersion (SSD) tablet that dissolves in water in the stomach without the help of bile acids. It is hoped that this may help the study drug to work better at a lower dose.REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0451
Date of REC Opinion
24 May 2023
REC opinion
Favourable Opinion