Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE) (OHE)

March 17, 2023 updated by: Bausch Health Americas, Inc.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)

Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary objective of this study is to assess the efficacy of rifaximin SSD plus lactulose versus placebo plus lactulose for the treatment of overt hepatic encephalopathy (OHE). The secondary objectives of this study are to assess the safety of rifaximin SSD in subjects with OHE and to assess the effects of treatment with rifaximin SSD on key secondary endpoints.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Corona Del Mar, California, United States, 92118
        • Bausch Health Site 18
      • Los Angeles, California, United States, 90033
        • Bausch Health Site 15
      • Los Angeles, California, United States, 90048
        • Bausch Health Site 19
      • San Francisco, California, United States, 94143
        • Bausch Health Site 04
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Bausch Health Site 13
    • Florida
      • Miami, Florida, United States, 33136
        • Bausch Health Site 08
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Bausch Health Site 05
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Bausch Health Site 33
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Bausch Health Site 03
    • Michigan
      • Detroit, Michigan, United States, 48109
        • Bausch Health Site 07
      • Detroit, Michigan, United States, 48127
        • Bausch Health 01
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Bausch Health Site 25
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Bausch Health Site 24
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Bausch Health Site 27
    • New York
      • Brooklyn, New York, United States, 11215
        • Bausch Health Site 36
      • New York, New York, United States, 10029
        • Bausch Health Site 09
      • New York, New York, United States, 10065
        • Bausch Health Site 28
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Bausch Health Site 17
      • Columbus, Ohio, United States, 43210
        • Bausch Health Site 23
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Bausch Health Site 11
      • Philadelphia, Pennsylvania, United States, 19107
        • Bausch Health Site 26
      • Philadelphia, Pennsylvania, United States, 19141
        • Bausch Health Site 10
      • Pittsburgh, Pennsylvania, United States, 15213
        • Bausch Health Site 12
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Bausch Health Site 16
    • Texas
      • Dallas, Texas, United States, 75203
        • Bausch Health Site 22
      • Dallas, Texas, United States, 75246
        • Bausch Health Site 35
      • Dallas, Texas, United States, 75390
        • Bausch Health Site 31
      • Houston, Texas, United States, 77001
        • Bausch Health Site 02
      • Houston, Texas, United States, 77030
        • Bausch Health Site 37
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Bausch Health Site 30
      • Richmond, Virginia, United States, 23249
        • Bausch Health Site 06
    • Washington
      • Seattle, Washington, United States, 98104
        • Bausch Health Site 21
      • Seattle, Washington, United States, 98195
        • Bausch Health Site 14
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Bausch Health Site 20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female age 18 to 75 years of age (inclusive) at the time of screening.
  • Females of childbearing potential, defined as a female who is fertile following menarche, must have a negative serum pregnancy test at screening and agree to use an acceptable method of contraception throughout their participation in the study.

Note: Female subjects who have been surgically sterilized (e.g., hysterectomy or bilateral tubal ligation) or who are postmenopausal (defined as total cessation of menses for > 1 year) will not be considered "female subjects of childbearing potential".

  • Subject is hospitalized with liver cirrhosis and/or OHE and has a confirmed diagnosis of OHE at Baseline.
  • Subject has a Grade 2 or Grade 3 HE episode according to the HE Grading Instrument (HEGI) following 8 to 12 hours of intravenous (IV) hydration and lactulose treatment.

Exclusion Criteria:

  • Subject has an uncontrolled major psychiatric disorder including major depression or psychoses as determined by the investigator.
  • Subject has been diagnosed with an infection for which they are currently taking oral or parenteral antibiotics, which cannot be discontinued at time of enrollment. Note: Subjects currently taking Rifaximin are not excluded
  • Subject shows presence of intestinal obstruction or has inflammatory bowel disease.
  • Subject has uncontrolled Type 1 or Type 2 diabetes. Note: Subjects with controlled diabetes may be enrolled if they are on stable doses of oral hypoglycemic drugs for at least 3 months prior to screening, and demonstrate clinically acceptable blood glucose control at Baseline, as determined by the investigator.
  • Subject has an active malignancy (exceptions: non-melanoma skin cancers).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1 40 mg Rifaximin SSD once daily
40 mg Rifaximin immediate release (IR) rifaximin SSD once daily (QD) and lactulose
Drug: 40 mg Rifaximin SSD once daily
SSD once daily (QD)
Experimental: Cohort 2 40 mg Rifaximin SSD twice daily
40 mg Rifaximin immediate release (IR) rifaximin SSD twice daily (BID) and lactulose
Drug: 40 mg Rifaximin SSD twice daily
SSD twice daily (BID)
Experimental: Cohort 3 80 mg Rifaximin SSD once daily
80 mg Rifaximin sustained extended release (SER) rifaximin SSD once daily (QD) and lactulose
Drug: 80 mg Rifaximin SSD once daily
SSD once daily (QD)
Experimental: Cohort 4 80 mg Rifaximin SSD twice daiy
80 mg Rifaximin sustained extended release (SER) rifaximin SSD twice daily (BID) and lactulose
Drug: 80 mg Rifaximin SSD twice daily
SSD twice daily (BID)
Experimental: Cohort 5 Placebo twice daily
SSD placebo twice daily (BID) and lactulose
Drug: Placebo
Administered twice daily (BID)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Overt Hepatic Encephalopathy (OHE) Resolution Determined Using the Hepatic Encephalopathy Grading Instrument (HEGI), Defined as HEGI Score < 2
Time Frame: 14 days
A participant was considered to have an overt HE episode if at least one of the following applied: (1) Disorientated to time or place or person, (2) Lethargic and has asterixis, (3) Inability to assess the patient due to disorientation to time and place and person; and/or somnolence, and/or coma. Severity of OHE episodes was graded using the HEGI scale, where Grade 1 is no clinical findings of OHE, and Grade 4 is comatose. Higher scores on the scale have higher severity (worse outcome).
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Improvement in Hepatic Encephalopathy Grading Instrument (HEGI) Score, Defined as at Least One Grade Decrease (Improvement)
Time Frame: 14 days
A participant was considered to have an overt HE episode if at least one of the following applied: (1) Disorientated to time or place or person, (2) Lethargic and has asterixis, (3) Inability to assess the patient due to disorientation to time and place and person; and/or somnolence, and/or coma. Severity of OHE episodes was graded using the HEGI scale, where Grade 1 is no clinical findings of OHE, and Grade 4 is comatose. Higher scores on the scale have higher severity (worse outcome).
14 days
Time to Hospital Discharge
Time Frame: 14 days
Time in days until discharge from the hospital
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch Health Americas, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNHE2041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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