Hepatic EncephalopathyPhase 3NCT00364689

RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial

A Phase 3 study testing Rifaximin and Lactulose in people with Hepatic Encephalopathy, run by University of Miami at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to compare the effectiveness of three different treatments for 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 and Lactulose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 1 siteUnited States
Study dates: Aug 2006to Jul 2008
Phase: Phase 3
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

Cirrhosis of any cause
History of previous admission for acute HE within 12 months of screening and Conn grade 0-1 HE at time of enrollment
An Institutional Review Board (IRB/EC) approved informed consent is signed and dated prior to any study-related activities being initiated.
Subject is a male or a non-pregnant and non-lactating female. Women of non-childbearing potential or who are practicing adequate birth control are eligible. The investigator is responsible for determining whether the subject has adequate birth control for study participation.
Subject is ≥18 years of age.
Subject is capable and willing to comply with all study procedures.
If the subject has a history of a portal-systemic shunt, shunt placement or revision must be >6 months from Screening for TIPS or a surgical shunt.

Who cannot join

Subject has a significant medical or psychiatric condition which, in the opinion of the Investigator, precludes participation in the study.
Subject has a history of allergy or intolerance to lactulose.
Subject has a history of allergy or intolerance to rifampin or rifaximin.
Subject has participated in an investigational drug or device study within the 30 days prior to study screening.
Subject is pregnant or is lactating.
Subject shows evidence of ongoing alcohol or drug dependence, in the opinion of the Investigator.

Show all 14Show fewer

Subject has a visual impairment disorder (e.g., glaucoma, diabetic retinopathy, or macular degeneration) or a neurological disease beyond HE that, in the opinion of the Investigator, could impact their performance on neuropsychological assessments and psychometric tests.
Subject has any condition or circumstance that would, in the opinion of the Investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.
Subject's current, required medications are on prohibited concurrent medication listing.
Hemoglobin < 8.0 at time of screening
Severe hypovolemia or electrolyte abnormalities that would be likely to affect mental function (serum sodium less than 120 mEq/L, serum calcium greater than 11 mg/dL) at time of screening
Ongoing gastrointestinal bleeding at time of screening
Chronic renal insufficiency with a serum creatinine > 3.0 at time of screening
History of tuberculosis infection

Trial locations and contacts

1 site in 1 country.

United States1 site

Center For Liver Diseases - University of Miami
Miami, Florida, 33136

Other trials in United States

About this study

The purpose of this study is to compare the effectiveness of three different treatments for hepatic encephalopathy.

Conditions: Hepatic Encephalopathy
Being tested: Rifaximin, Lactulose, Placebo
Keywords: Encephalopathy, Hepatic, Portosystemic Encephalopathy, Encephalopathy, Hepatocerebral, Encephalopathy, Portal-Systemic, Encephalopathy, Portosystemic, Hepatic Coma, Hepatic Stupor, Hepatocerebral Encephalopathy, Portal-Systemic Encephalopathy
Medical subject headings: Hepatic Encephalopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RifaximinDrug
LactuloseDrug
PlaceboOther

Study groups in NCT00364689
Study group	Role	What they receive
lactulose given with a placebo (sugar pill)	Experimental	Not described Receives: Drug: Lactulose; Other: Placebo
lactulose given with rifaximin	Experimental	Not described Receives: Drug: Rifaximin; Drug: Lactulose
rifaximin given alone	Active comparator	Not described Receives: Drug: Rifaximin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Hospitalizations for Hepatic Encephalopathy (HE)
Measured: Month 7
Changes in Psychometric Testing During Study Period
Measured: Month 7

Secondary outcomes (3)

Number of Hospitalization Days for All Causes
Measured: Month 7
Death or Survival to Liver Transplantation
Measured: Month 7
Rate of Adverse Events With Rifaximin Treatment
Measured: Month 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2006Jul 2008

First posted16 Aug 2006 (estimated)
Study startAug 2006
Primary completionJul 2008
Study completionJul 2008

Why it stopped: Difficult to recruit participants

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 University of MiamiThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00364689
Sponsor's protocol ID: 20060006
Other IDs: 20060298
Status last verified: Aug 2019
First submitted: 15 Aug 2006
Last updated: 17 Sep 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatic Encephalopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT00364689
Acronym / sponsor ID: 20060006
Conditions: Hepatic Encephalopathy
Keywords: Encephalopathy, Hepatic, Portosystemic Encephalopathy, Encephalopathy, Hepatocerebral, Encephalopathy, Portal-Systemic, Encephalopathy, Portosystemic, Hepatic Coma, Hepatic Stupor, Hepatocerebral Encephalopathy
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficult to recruit participants
Enrolment: 13 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: Bausch Health Americas, Inc.
Study start: Aug 2006 (actual)
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 16 Aug 2006 (estimated)
Results: Posted 17 Sep 2019

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 this study is to compare the effectiveness of three different treatments for hepatic encephalopathy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
lactulose given with a placebo (sugar pill)	Experimental	Drug: Lactulose, Other: Placebo
lactulose given with rifaximin	Experimental	Drug: Rifaximin, Drug: Lactulose
rifaximin given alone	Active comparator	Drug: Rifaximin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Cirrhosis of any cause
History of previous admission for acute HE within 12 months of screening and Conn grade 0-1 HE at time of enrollment
An Institutional Review Board (IRB/EC) approved informed consent is signed and dated prior to any study-related activities being initiated.
Subject is a male or a non-pregnant and non-lactating female. Women of non-childbearing potential or who are practicing adequate birth control are eligible. The investigator is responsible for determining whether the subject has adequate birth control for study participation.
Subject is ≥18 years of age.

Key exclusion criteria (14 listed)

Subject has a significant medical or psychiatric condition which, in the opinion of the Investigator, precludes participation in the study.
Subject has a history of allergy or intolerance to lactulose.
Subject has a history of allergy or intolerance to rifampin or rifaximin.
Subject has participated in an investigational drug or device study within the 30 days prior to study screening.
Subject is pregnant or is lactating.

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
Rifaximin	Drug	lactulose given with rifaximin, rifaximin given alone
Lactulose	Drug	lactulose given with a placebo (sugar pill), lactulose given with rifaximin
Placebo	Other	lactulose given with a placebo (sugar pill)

Primary outcome

Number of Hospitalizations for Hepatic Encephalopathy (HE)
Time frame: Month 7
Changes in Psychometric Testing During Study Period
Time frame: Month 7

3 secondary outcomes

Number of Hospitalization Days for All Causes
Time frame: Month 7
Death or Survival to Liver Transplantation
Time frame: Month 7
Rate of Adverse Events With Rifaximin Treatment
Time frame: Month 7

Results and safety

Results posted to the registry on 17 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	13	12

Primary outcome: Number of Hospitalizations for Hepatic Encephalopathy (HE)

Time frame: Month 7

Population analysed: Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.

Primary outcome: Changes in Psychometric Testing During Study Period

Time frame: Month 7

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Seven months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Study Participants	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatic Encephalopathy

Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
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Not yet recruitingPhase 4
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
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Not yet recruiting
Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy
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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
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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.

Chakradhar Reddy, MD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rifaximin and Lactulose in people with Hepatic Encephalopathy, run by University of Miami at 1 site 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 7 inclusion and 14 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 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Sep 2019). 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?

Number of Hospitalizations for Hepatic Encephalopathy (HE) (time frame: Month 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00364689.

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 17 Sep 2019.