Hepatic EncephalopathyPhase 4NCT01846663
Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
A Phase 4 study testing Rifaximin in people with Hepatic Encephalopathy, run by Bausch Health Americas, Inc. at 28 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- Rifaximin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 28 sitesUnited States
- Study dates
- 3 Apr 2013to 22 Feb 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-breast feeding female ≥ 18 years old
- In remission from demonstrated overt HE
- Had ≥1 episode of overt HE associated with liver disease within the last 6 months
- MELD score of ≥ 19
- Has a close family member or other personal contact who is familiar with the subject's HE, can provide continuing oversight to the subject and is willing to be available to the subject during the conduct of the trial
Who cannot join
- HIV
- History of tuberculosis infection
- Chronic respiratory insufficiency
- Current infection and receiving antibiotics
- Renal insufficiency requiring dialysis
- Active spontaneous bacterial peritonitis infection
Show all 10Show fewer
- Intestinal obstruction or has inflammatory bowel disease
- Active malignancy within the last 5 years
- Current GI bleeding or has had a GI hemorrhage within past 3 months
- Anemia
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
University of Colorado Denver
Aurora, Colorado, 80045
The University of Alabama at Birmingham
Birmingham, Alabama, 35294-0111
Northwestern University-Comprehensive Transplant Center
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Southern California Liver Centers
Coronado, California, 92118
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
Brook Army Medical Center
Fort Sam Houston, Texas, 78234
Salix Site
Galveston, Texas, 77555
The Methodist Hospital
Houston, Texas, 77030
UCSD Clinical & Translational Research Institute
La Jolla, California, 92037
Loma Linda University Medical Center Transplantation Institute
Loma Linda, California, 92324
University of Southern Califorina Keck School Of Medicine
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1610
Salix Site
New Haven, Connecticut, 06520
Tulane Abdominal Transplant Research Office
New Orleans, Louisiana, 70112
New York University School of Medicine
New York, New York, 10016
Banner Research
Phoenix, Arizona, 85016
Salix Site
Portland, Oregon, 97239
Inland Empire Liver Foundation
Rialto, California, 92377
McGuire VA Medical Center
Richmond, Virginia, 23249
VCU/MCV Health Systems
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
Swedish Medical Center
Seattle, Washington, 98122
Washington University
St Louis, Missouri, 63110
Salix Site
Tampa, Florida, 33606
University Of Arizona Liver Research Institute
Tucson, Arizona, 85724
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy, Safety, And Pharmacokinetics Of Rifaximin 550 Mg In Subjects With Severe Hepatic Impairment And Overt Hepatic Encephalopathy
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
- Conditions
- Hepatic Encephalopathy
- Being tested
- Placebo, Rifaximin
- Keywords
- Hepatic Encephalopathy, Liver Failure, Hepatic Insufficiency, Liver Diseases, Brain Diseases, Rifaximin, Cirrhosis
- Medical subject headings
- Hepatic Encephalopathy, Liver Failure, Hepatic Insufficiency, Liver Diseases, Brain Diseases, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo, oral, 0 mg BID, 6 months of treatment
RifaximinDrug
Also called XIFAXAN® Tablets
Rifaximin, oral, 550 mg BID, 6 months treatment
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin | Experimental | Rifaximin, oral, 550 mg BID, 6 months of treatment Receives: Drug: Rifaximin |
| Placebo | Placebo comparator | Placebo, oral, 0 mg BID, 6 months of treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode
Measured: 6 Months
Secondary outcomes (1)
Proportion of Participants With HE-related Hospitalization
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study start3 Apr 2013
- Primary completion22 Feb 2016
- Study completion22 Feb 2016
Why it stopped: Study was determined to be infeasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Varsha Bhatt, Ph.D., Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846663
- Sponsor's protocol ID
- RFHE4043
- Status last verified
- Jan 2024
- First submitted
- 24 Apr 2013
- Last updated
- 9 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy, Safety, And Pharmacokinetics Of Rifaximin 550 Mg In Subjects With Severe Hepatic Impairment And Overt Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT01846663
- Acronym / sponsor ID
- RFHE4043
- Conditions
- Hepatic Encephalopathy
- Keywords
- Hepatic Encephalopathy, Liver Failure, Hepatic Insufficiency, Liver Diseases, Brain Diseases, Rifaximin, Cirrhosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was determined to be infeasible.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2013 (actual)
- Primary completion
- 22 Feb 2016 (actual)
- Study completion
- 22 Feb 2016 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 9 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin | Experimental | Drug: RifaximinRifaximin, oral, 550 mg BID, 6 months of treatment |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, oral, 0 mg BID, 6 months of treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or non-pregnant, non-breast feeding female ≥ 18 years old
- In remission from demonstrated overt HE
- Had ≥1 episode of overt HE associated with liver disease within the last 6 months
- MELD score of ≥ 19
- Has a close family member or other personal contact who is familiar with the subject's HE, can provide continuing oversight to the subject and is willing to be available to the subject during the conduct of the trial
Key exclusion criteria (10 listed)
- HIV
- History of tuberculosis infection
- Chronic respiratory insufficiency
- Current infection and receiving antibiotics
- Renal insufficiency requiring dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo, oral, 0 mg BID, 6 months of treatment | Drug | Placebo |
| RifaximinAlso: XIFAXAN® TabletsRifaximin, oral, 550 mg BID, 6 months treatment | Drug | Rifaximin |
Primary outcome
Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode
Time frame: 6 Months
1 secondary outcome
Proportion of Participants With HE-related Hospitalization
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
Related trials for Hepatic Encephalopathy
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
Not yet recruitingPhase 4
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
Liver Cirrhosis, Sleep Disturbance
Not yet recruiting
Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy
Liver Cirrhosis, Hepatic Encephalopathy (HE)
Recruiting
4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis
Cirrhosis, Portal Hypertension
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Varsha Bhatt, Ph.D. study director
Bausch Health Americas, Inc.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifaximin in people with Hepatic Encephalopathy, run by Bausch Health Americas, Inc. at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.