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NCT05071716 (Rifaximin SSD in Hepatic Encephalopathy): BVCT ex-ante prediction vs. reported outcome

On 20 Jul 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 23 Jan 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05071716
Acronym
RED-C-3131
Drug Name
Rifaximin SSD
Drug MoA
non-systemic antibiotic
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Digestive System Diseases
Indication
Hepatic Encephalopathy
Human Patients
524
Sponsor
Bausch Health Companies
Phase
Phase 3

Prediction of , index 1689

Prospective Prediction
Prediction Index
1689
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in hepatic encephalopathy-related hospitalization/mortality inferior to lactulose)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in time to first event of overt hepatic encephalopathy requiring hospitalization against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
552 days in advance
Readout Data Interpretation
rifaximin SSD did not meet primary endpoint of delaying first HE episode in patients with no prior history; safe and well-tolerated
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

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
Phase
Phase 3
Status
Active not recruiting
Enrollment
524
Lead sponsor
Bausch Health Americas, Inc.
Conditions
Hepatic Encephalopathy
Interventions
DRUG: Rifaximin SSD; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Prevention
Start
2022-04-07
Primary completion
2025-09
Completion
2025-09
Primary outcomes
  • Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death. (72 weeks)

NCT05071716 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials