Brief Summary
Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.
Brief Title
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Hepatic Encephalopathy
Eligibility Criteria
Key Inclusion Criteria:
* Diagnosis of liver cirrhosis with medically controlled ascites (\>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past).
* Conn (West Haven Criteria) score of \< 2.
* Mini-Mental State Examination (MMSE) score \> 24 at screening.
* ≥ 18 and ≤ 85 years of age.
Key Exclusion Criteria:
* Active COVID-19 that is unresolved
* History of SBP
* History of EVB or AKI-HRS within 6 months
* History of OHE episode (Conn score ≥ 2)
* Diagnosis of liver cirrhosis with medically controlled ascites (\>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past).
* Conn (West Haven Criteria) score of \< 2.
* Mini-Mental State Examination (MMSE) score \> 24 at screening.
* ≥ 18 and ≤ 85 years of age.
Key Exclusion Criteria:
* Active COVID-19 that is unresolved
* History of SBP
* History of EVB or AKI-HRS within 6 months
* History of OHE episode (Conn score ≥ 2)
Inclusion Criteria
Inclusion Criteria:
* Diagnosis of liver cirrhosis with medically controlled ascites (\>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past).
* Conn (West Haven Criteria) score of \< 2.
* Mini-Mental State Examination (MMSE) score \> 24 at screening.
* ≥ 18 and ≤ 85 years of age.
* Diagnosis of liver cirrhosis with medically controlled ascites (\>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past).
* Conn (West Haven Criteria) score of \< 2.
* Mini-Mental State Examination (MMSE) score \> 24 at screening.
* ≥ 18 and ≤ 85 years of age.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
18 Years
NCT Id
NCT05297448
Org Class
Industry
Org Full Name
Bausch Health Americas, Inc.
Org Study Id
RNLC3132
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
Primary Outcomes
Outcome Measure
Time to first event of overt hepatic encephalopathy requiring hospitalization
Outcome Time Frame
72 weeks
Secondary Outcomes
Outcome Time Frame
72 weeks
Outcome Measure
Time to first Conn score ≥ 2
Outcome Time Frame
72 weeks
Outcome Measure
Time to all-cause hospitalization
Outcome Time Frame
72 weeks
Outcome Measure
Time to first event of OHE that requires hospitalization, or all-cause death
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Brett Fortune
Investigator Email
bfortune@montefiore.org