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

NCT00364689 | Terminated Phase 3 Results

• 2 other identifiers: 2006000620060298
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatic Encephalopathy

Keywords

Encephalopathy, Hepatic; Portosystemic Encephalopathy; Encephalopathy, Hepatocerebral; Encephalopathy, Portal-Systemic; Encephalopathy, Portosystemic; Hepatic Coma; Hepatic Stupor; Hepatocerebral Encephalopathy; Portal-Systemic Encephalopathy

Outcome Measures

Primary Outcomes (2)

• Number of Hospitalizations for Hepatic Encephalopathy (HE)

  Month 7

• Changes in Psychometric Testing During Study Period

  Month 7

Secondary Outcomes (3)

• Number of Hospitalization Days for All Causes

  Month 7

• Death or Survival to Liver Transplantation

  Month 7

• Rate of Adverse Events With Rifaximin Treatment

  Month 7

Study Arms (3)

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

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Miami: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

Center For Liver Diseases - University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Rifaximin; Lactulose

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Limitations and Caveats

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.

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: University of Miami

y.p.davis@med.miami.edu

305-243-0494

Study Officials

• Chakradhar Reddy, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2006
• First Posted: August 16, 2006
• Study Start: August 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: September 17, 2019
• Results First Posted: September 17, 2019

Record last verified: 2019-08

Locations

US (1)