Status:
ACTIVE_NOT_RECRUITING
Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 hepa...
Eligibility Criteria
Inclusion
- Key
- 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
- 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)
Key Trial Info
Start Date :
August 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT05297448
Start Date
August 3 2022
End Date
January 1 2026
Last Update
September 10 2025
Active Locations (188)
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1
Bausch Site 591
Homewood, Alabama, United States, 35209
2
Bausch Site 445
Chandler, Arizona, United States, 85224
3
Bausch Site 453
Sun City, Arizona, United States, 85351
4
Bausch Site 587
Tucson, Arizona, United States, 85715