2022-502899-23-00
Active, not recruiting
Phase 3
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)
Salix Pharmaceuticals Inc.63 sites in 8 countries194 target enrollmentStarted: August 10, 2023Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Salix Pharmaceuticals Inc.
- Enrollment
- 194
- Locations
- 63
- Primary Endpoint
- Time to first event of OHE requiring hospitalization. • A thorough evaluation of the patient will be carried out to confirm the diagnosis of OHE, which will be made by a trained medical professional (e.g., MD, DO) using American Association for the Study of Liver Disease Guidelines. • Every OHE diagnosis will be evaluated and confirmed to meet endpoint definitions by the Clinical Event Adjudication Committee (CEAC).
Overview
Brief Summary
The primary objective of this study is to assess the efficacy of rifaximin SSD-40IR versus placebo to delay the occurrence of HE-related hospitalization.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •A participant will be eligible for inclusion in this study if he/she meets all of the following criteria:
- •Participant has a diagnosis of liver cirrhosis with medically controlled ascites (> 30 days). Cirrhosis diagnosis can be made using any of the following: o Histopathological evidence of cirrhosis o Magnetic resonance imaging (MRI) o Computed tomography (CT) o Fibroscan (Transient Elastography) o Imaging (sonographic or cross-sectional) o Presence of esophageal varices o Thrombocytopenia (<150,000/μL) in participants with CLD Medically controlled ascites (>30 days) includes: o Ascites that is controlled by diet and/or medication for over 30 days and that does not require recurring therapeutic paracentesis (could have had paracentesis in the past).
- •Participant has a Conn (West Haven Criteria [WHC]) score of <
- •Participant has a Mini-Mental State Examination (MMSE) score > 24 at screening.
- •Participant is ≥ 18 and ≤ 85 years of age.
- •Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening. All participants must agree to use highly effective methods of contraception throughout their participation in the study.
- •Participant must be able to independently read, fully understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form (ICF) without additional support and provide authorization as appropriate per local privacy regulations.
Exclusion Criteria
- •Participant has an active COVID-19 infection that is unresolved or, in the opinion of the investigator, may affect evaluation of the study drug or might place the subject at undue risk.
- •Participant has a history of substance abuse < 6 months prior to signing the ICF and cannot refrain from substance abuse during the study period. For alcohol abuse, participants undergoing alcohol use counselling or receiving Alcohol Use Disorder pharmacotherapy, can be considered for inclusion.
- •Participants on antipsychotic medications should be excluded irrespective of indication or dose. Participants who discontinue psychoactive medications with a washout period of 30 days before providing consent are allowed. Benzodiazepine, psychoactive medicine, and opioid use are excluded, with the exception of: a. Participants on stable dose psychoactive medicines may be included. b. Participants are allowed to remain on opioids, if on a stable opioid dose for at least 30 days.
- •Participant has been diagnosed with an uncontrolled infection < 4 weeks prior to screening.
- •Participant has been diagnosed with an upper gastrointestinal bleed from non-variceal sources < 6 weeks prior to screening.
- •Participant shows presence of intestinal obstruction or has inflammatory bowel disease.
- •Participant has undergone bariatric surgery or intestinal resection. Limited segmental resection of colon (e.g., adenomatous polyp) > 2 years prior is allowed.
- •Participant has a history of an acute portal vein thrombosis that requires anticoagulants within the past 3 months, a history of a TIPS procedure, or plans to undergo a TIPS procedure.
- •Participant has a history of shunt surgery or direct intrahepatic portocaval shunt (DIPS) procedure for portal hypertension or plans to undergo a DIPS procedure.
- •Participant requires peritoneal dialysis or hemodialysis.
Outcomes
Primary Outcomes
Time to first event of OHE requiring hospitalization. • A thorough evaluation of the patient will be carried out to confirm the diagnosis of OHE, which will be made by a trained medical professional (e.g., MD, DO) using American Association for the Study of Liver Disease Guidelines. • Every OHE diagnosis will be evaluated and confirmed to meet endpoint definitions by the Clinical Event Adjudication Committee (CEAC).
Time to first event of OHE requiring hospitalization. • A thorough evaluation of the patient will be carried out to confirm the diagnosis of OHE, which will be made by a trained medical professional (e.g., MD, DO) using American Association for the Study of Liver Disease Guidelines. • Every OHE diagnosis will be evaluated and confirmed to meet endpoint definitions by the Clinical Event Adjudication Committee (CEAC).
Secondary Outcomes
- Time to first Conn score ≥ 2
- Time to all-cause hospitalization
- Time to first event of OHE that requires hospitalization, or all-cause death
Investigators
Clinical trial information desk
Scientific
Salix Pharmaceuticals Inc.
Study Sites (63)
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