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NCT01904409
A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications in Subjects With Early Decompensated Liver Cirrhosis
Phase 2 trial testing Placebo in Liver Cirrhosis in 420 participants. Completed in 1 July 2015.
1 June 2015
Quick facts
| Lead sponsor | Bausch Health Americas, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 420 |
| Start date | 1 June 2013 |
| Primary completion | 1 June 2015 |
| Estimated completion | 1 July 2015 |
| Sites | 120 locations across United States, Russia |
Drugs / interventions tested
- Placebo
- Rifaximin SSD 40 mg IR tablet — full drug profile →
- Rifaximin SSD 80 mg IR tablet — full drug profile →
- Rifaximin SSD 40 mg SER tablet — full drug profile →
- Rifaximin SSD 80 mg SER tablet — full drug profile →
- Rifaximin SSD 80mgIR/80mgSER tablet — full drug profile →
Conditions studied
- Liver Cirrhosis — all drugs for Liver Cirrhosis →
Sponsor
Bausch Health Americas, Inc. — full company profile →
Who can join
18 and older, any sex, with Liver Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Time to all-cause mortality or hospitalization that is attributable to complications of liver disease.
Time frame: Weeks 1 through 24
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.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Antibiotic prophylaxis to prevent spontaneous bacterial peritonitis in people with liver cirrhosis: a network meta-analysis.
Komolafe O, Roberts D, Freeman SC, Wilson P, et al · · 2020 · cited 30× · PMID 31978256 · DOI 10.1002/14651858.cd013125.pub2 -
<b>UEG</b> Week 2020 Poster Presentations.
· 2020 · cited 5× · PMID 33043826 · DOI 10.1177/2050640620927345
Verify or expand the search:
- PubMed search for NCT01904409
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rifaximin SSD 40 mg IR tablet
Trials testing the same drug.
- NCT06718686 — Rifaximin SSD in Dementia Trial · Phase 1, PHASE2 · recruiting
Other recruiting trials for Liver Cirrhosis
Currently open trials in the same condition.
- NCT07439939 — Exploration of Systemic and Portal Hemostasis in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Place · recruiting
- NCT07325526 — A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- · Phase 2 · recruiting
- NCT07418008 — The Liver Cirrhosis Cognitive Decline Scale (LiCCoS) · recruiting
- NCT07201649 — Roles of Hepatic Insufficiency, Hepatic Fibrosis, and Inorganic Pyrophosphate in the Progression of Arterial Calcificati · NA · recruiting
- NCT07252102 — Effect of HFNC on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients · NA · recruiting
Other Bausch Health Americas, Inc. trials
Trials by the same sponsor.
- NCT07285785 — Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea · Phase 4 · recruiting
- NCT07428538 — Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH) · Phase 3 · recruiting
- NCT05098028 — Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease · Phase 2 · completed
- NCT05027282 — Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatm · NA · completed
- NCT05132231 — Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Wor · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01904409 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bausch Health Americas, Inc.
- Last refreshed: 15 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01904409.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing