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NCT01904409 · ClinicalTrials.gov registry record · Phase 2
Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis
A Phase 2 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 2
- Development phase
- 420
- Enrollment target
NCT01904409: Completed Phase 2 study, sponsored by Bausch Health Americas.
NCT01904409 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 420 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (216% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01904409, a Phase 2 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 420 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the efficacy of rifaximin SSD versus placebo in preventing complications of liver cirrhosis, such as all-cause mortality (death due to all causes) or hospitalization, in subjects with early decompensated liver cirrhosis. Rifaximin, a non-systemic antibacterial agent, is currently marketed as a 550 mg tablet for the reduction in risk of recurrent overt hepatic encephalopathy, a complication of liver cirrhosis. The rifaximin SSD tablet was formulated to maximize the efficacy of rifaximin. Subjects will receive 1 of 5 doses of rifaximin SSD tablets or placebo tablets every day for 24 weeks.
Primary Outcome
The primary outcome measure will evaluate the time from start of the treatment period to death due to any cause (all-cause mortality) or hospitalization due to complications of liver disease for each patient during the 24-week treatment period.
Interventions
- DRUG Placebo
- DRUG Rifaximin SSD 40 mg IR tablet
- DRUG Rifaximin SSD 80 mg IR tablet
- DRUG Rifaximin SSD 40 mg SER tablet
- DRUG Rifaximin SSD 80 mg SER tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT01904409 record still lists
NCT01904409 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (216% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01904409 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01904409 about?
NCT01904409 is a clinical study titled "Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis". The primary objective of this study is to assess the efficacy of rifaximin SSD versus placebo in preventing complications of liver cirrhosis, such as all-cause mortality (death due to all causes) or hospitalization, in subjects with early decompensated liver cirrhosis. Rifaximin, a non-systemic ant...
What is the current status of trial NCT01904409?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 420 participants. The study started on 2013-06. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01904409?
The interventions under investigation include: Placebo (DRUG), Rifaximin SSD 40 mg IR tablet (DRUG), Rifaximin SSD 80 mg IR tablet (DRUG), Rifaximin SSD 40 mg SER tablet (DRUG), Rifaximin SSD 80 mg SER tablet (DRUG).
Who is sponsoring clinical trial NCT01904409?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01904409's enrollment target sits among peer trials
420 91st of 2000 higher than 1,910 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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