Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode
Primary
· 6 Months
| Group | Value | 95% CI |
|---|---|---|
| Rifaximin | 1 | |
| Placebo | 1 |
Last reviewed · How we verify
NCT01846663
Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
Terminated
Phase 4
Results posted
Last updated 9 January 2024
What this trial tests
Phase 4 trial testing Placebo in Hepatic Encephalopathy in 6 participants. Terminated before completion.
Timeline
3 April 2013
Primary endpoint
22 February 2016
22 February 2016
22 February 2016
Quick facts
| Lead sponsor | Bausch Health Americas, Inc. |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 3 April 2013 |
| Primary completion | 22 February 2016 |
| Estimated completion | 22 February 2016 |
| Sites | 28 locations across United States |
Drugs / interventions tested
- Placebo
- Rifaximin (rifaximin) — full drug profile →
Conditions studied
- Hepatic Encephalopathy — all drugs for Hepatic Encephalopathy →
Sponsor
Bausch Health Americas, Inc. — full company profile →
Who can join
18 and older, any sex, with Hepatic Encephalopathy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Participants With HE-related Hospitalization
Secondary
· 6 Months
| Group | Value | 95% CI |
|---|---|---|
| Rifaximin | 1 | |
| Placebo | 1 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Rifaximin
Serious: 3/3 (100%)
Deaths: 2/3
Placebo
Serious: 1/3 (33%)
Deaths: 1/3
Serious adverse events (14 terms)
| Reaction | System | Rifaximin | Placebo |
|---|---|---|---|
| Hepatic cirrhosis | Hepatobiliary disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Renal failure acute | Renal and urinary disorders | — | — |
| Septic shock | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Ascites | Gastrointestinal disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Hepatic encephalopathy | Nervous system disorders | — | — |
| Hepatorenal syndrome | Hepatobiliary disorders | — | — |
| Non-alcoholic steatohepatitis | Hepatobiliary disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Liver disorder | Hepatobiliary disorders | — | — |
| Peritonitis bacterial | Infections and infestations | — | — |
Other adverse events (21 terms — click to expand)
| Reaction | System | Rifaximin | Placebo |
|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | — | — |
| Ammonia increased | Investigations | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Anosmia | Nervous system disorders | — | — |
| Disturbance in attention | Nervous system disorders | — | — |
| Dysesthesia | Nervous system disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Dyslipidemia | Metabolism and nutrition disorders | — | — |
| Escherichia infection | Infections and infestations | — | — |
| Fatigue | General disorders | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — |
| Hypothermia | General disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| International normalized ratio increased | Investigations | — | — |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Edema peripheral | General disorders | — | — |
| Prothrombin time prolonged | Investigations | — | — |
| Tremor | Nervous system disorders | — | — |
Most-reported serious reactions: Hepatic cirrhosis, Epistaxis, Respiratory failure, Renal failure acute, Septic shock, Sepsis, Ascites, Bronchitis.
Data from ClinicalTrials.gov NCT01846663 adverse events section.
Sponsor's own description
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Management of hepatic encephalopathy in the hospital.
Leise MD, Poterucha JJ, Kamath PS, Kim WR. · · 2014 · cited 59× · PMID 24411831 · DOI 10.1016/j.mayocp.2013.11.009 -
Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis.
Zacharias HD, Kamel F, Kamel F, Tan J, et al · · 2023 · cited 22× · PMID 37467180 · DOI 10.1002/14651858.cd011585.pub2 -
Gut microbiota mediated molecular events and therapy in liver diseases.
Qi X, Yang M, Stenberg J, Dey R, et al · · 2020 · cited 20× · PMID 33505139 · DOI 10.3748/wjg.v26.i48.7603 -
Active Clinical Trials in Hepatic Encephalopathy: Something Old, Something New and Something Borrowed.
Balzano T. · · 2023 · cited 6× · PMID 36977964 · DOI 10.1007/s11064-023-03916-w
Verify or expand the search:
- PubMed search for NCT01846663
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT01846663 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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: 9 January 2024
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/NCT01846663.
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