Trial · NCT00686920

Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy

NCT00686920, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2019-08-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy. Trials, record NCT00686920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00686920

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
NCT number: NCT00686920
Status: Completed
Phases: Phase 3
Enrollment: 322 participants, actual
Lead sponsor: Bausch Health Americas, Inc.
Conditions: Hepatic Encephalopathy
Interventions: Rifaximin
First posted: 2008-05-30
Last updated: 2019-08-14
Results first posted: 2019-08-14

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event	Baseline up to Month 36	A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Secondary	Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants	Baseline up to Month 36	Hematology and blood chemistry with potentially significant values included: Hemoglobin \<9, \>18, or ≥3 (grams/deciliter \[g/dL\]) decrease from previous visit or ≥4 g/dL decrease from baseline; Hematocrit \<0.27%, \>0.54%, or ≥0.10% decrease from previous visit or ≥0.15% decrease from baseline; Platelets \<50 or \>400\10\^9/(liter \[L\]); Prothrombin time 9 seconds above baseline or upper limit of normal range; International normalized ratio \>1.7; White blood cells \<2.0 or \>12.0\10\^9/L; Lymphocytes \<13.5% or \>70%; Glucose, random, serum \<2.2 or \>16.5 millimole (mmol)/L; Potassium ≤3.0 or ≥5.5 mmol/L; Direct bilirubin increases 3-fold from baseline or \>85.5 micromole (umol)/L. Baseline value was defined as the last available value (including the applicable values from the participants who rolled over from Study RFHE3001) prior to the first dose of study drug. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Secondary	Number Of Participants With A Significant Mean Change From Baseline In Vital Signs	Baseline up to Month 36	Vital signs were measured and included sitting blood pressure, heart rate, oral temperature, and weight. These were collected at each scheduled study visit. Participants were placed supine for 5 minutes prior to each assessment of vital signs. Baseline value was defined as last available value (including the applicable values from the participants who rolled over from Study RFHE3001) prior to the first dose of study drug. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Secondary	Change From Baseline In Conn Score At Last Assessment	Baseline up to Month 36	The assessment for change in mental status during the study was measured by the Conn score (also known as the West Haven score). The following scale was used in the Conn scoring system: Grade 0=No personality or behavioral abnormality detected. Grade 1=Trivial lack of awareness, euphoria, or anxiety; shortened attention span; or impairment of addition or subtraction. Grade 2=Lethargy; disorientation for time; obvious personality change; and inappropriate behavior. Grade 3=Somnolence to semi-stupor, responsive to stimuli; confused; gross disorientation; and bizarre behavior. Grade 4=Coma, unable to test mental state. Participants entered the study with a Conn score of 0 to 2. Baseline value was defined as last available value (including the applicable values from the participants who rolled over from Study RFHE3001) prior to the first dose of study drug.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants	Baseline up to Month 36	All participants who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event	Baseline up to Month 36	All participants who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number Of Participants With A Significant Mean Change From Baseline In Vital Signs	Baseline up to Month 36	All participants who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline In Conn Score At Last Assessment	Baseline up to Month 36	All participants who received at least 1 dose of study drug.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants	New Rifaximin	Hemoglobin	15	Participants
Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants	Continuing Rifaximin	Hemoglobin	12	Participants
Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants	New Rifaximin	Hematocrit	12	Participants
Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants	Continuing Rifaximin	Hematocrit	4	Participants
Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants	New Rifaximin	Platelets	18	Participants
Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants	Continuing Rifaximin	Platelets	6	Participants
Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants	New Rifaximin	Prothrombin Time	16	Participants
Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants	Continuing Rifaximin	Prothrombin Time	7	Participants
Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants	New Rifaximin	International Normalized Ratio	24	Participants
Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants	Continuing Rifaximin	International Normalized Ratio	8	Participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	New Rifaximin	252
Overall Study	STARTED	Continuing Rifaximin	70
Overall Study	Received At Least 1 Dose Of Study Drug	New Rifaximin	252
Overall Study	Received At Least 1 Dose Of Study Drug	Continuing Rifaximin	70
Overall Study	COMPLETED	New Rifaximin	120
Overall Study	COMPLETED	Continuing Rifaximin	34
Overall Study	NOT COMPLETED	New Rifaximin	132
Overall Study	NOT COMPLETED	Continuing Rifaximin	36

Source ClinicalTrials.gov

Adverse events538

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	New Rifaximin	28	252
other	Anaemia	Blood and lymphatic system disorders	Continuing Rifaximin	7	70
other	Thrombocytopenia	Blood and lymphatic system disorders	New Rifaximin	9	252
other	Thrombocytopenia	Blood and lymphatic system disorders	Continuing Rifaximin	4	70
other	Nausea	Gastrointestinal disorders	New Rifaximin	52	252
other	Nausea	Gastrointestinal disorders	Continuing Rifaximin	15	70
other	Ascites	Gastrointestinal disorders	New Rifaximin	38	252
other	Ascites	Gastrointestinal disorders	Continuing Rifaximin	6	70
other	Vomiting	Gastrointestinal disorders	New Rifaximin	34	252
other	Vomiting	Gastrointestinal disorders	Continuing Rifaximin	8	70

1 to 10 of 538Source ClinicalTrials.gov

See all 538 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	New Rifaximin
Total, all-cause mortality	Continuing Rifaximin
Total, other adverse events	New Rifaximin	212	252
Total, other adverse events	Continuing Rifaximin	52	70
Total, serious adverse events	New Rifaximin	158	252
Total, serious adverse events	Continuing Rifaximin	49	70

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24365449	DERIVED	PubMed
37467180	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
New Rifaximin vs Continuing Rifaximin: Number Of Participants With A Significant Mean Change From Baseline In Vital Signs	Trial comparisons
New Rifaximin vs Continuing Rifaximin: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00686920

GET https://conductscience.org/api/trials/v1/NCT00686920/results?page=2

API reference For AI assistants