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

Hepatic Encephalopathy Clinical Trial

Official title:

A Multi-Center, Open-Label Trial to Evaluate the Long-Term Safety and Tolerability of Rifaximin 550 mg BID in Subjects With a History of Hepatic Encephalopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686920
• Other study ID #: RFHE3002
• Status: Completed
• Phase: Phase 3
• Start date: March 7, 2007
• Est. completion date: December 8, 2010

Study information

• Verified date: July 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look at the safety of a drug used in participants who have had hepatic encephalopathy (HE) in the past.

Description:

Eligible participants had a history of HE, a Conn score of 0 to 2 at enrollment, and either had successfully participated in a previous HE study with rifaximin (that is, RFHE3001 [NCT00298038]), or were new participants enrolled with ≥1 verifiable episode of HE (equivalent to a Conn score of ≥2) associated with cirrhosis or portal hypertension within 12 months of screening.

Successful participation in a previous rifaximin study was defined as having received ≥80% and ≤120% of the expected tablets, having been reasonably compliant with study procedures, and having not been discontinued from the previous study due to study drug-related Adverse Events. Participants who experienced HE or associated symptoms during or after the RFHE3001 study were considered eligible for entry into this open-label study if the participant and Investigator did not perceive study medication as a possible cause of the HE episode or associated symptoms. Participants who did not participate in a previous HE study with rifaximin were eligible if this open-label study was the only rifaximin HE study available at an individual site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: December 8, 2010
• Est. primary completion date: December 8, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must sign an Informed Consent Form

• In remission from past HE

• Appropriate birth control measures

• More than or equal to 18 years of age

• Must be potential for benefit from treatment

• Recent HE episodes

• Capable and willing to comply with all study procedures

• Participant has support network

Exclusion Criteria:

• Significant medical conditions or Investigator decision not to include the participant

• Allergies to the study drug or similar drugs

• Laboratory abnormalities

• Recent participation in another clinical trial

• Problems experienced in a previous HE trial

• Pregnant or at risk of pregnancy

• Recent alcohol consumption

• Active or latent bacterial or viral Infections

• Bowel issues

• Recent Active Cancer

• On a prohibited medication

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Drug:
• Rifaximin
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event	A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.	Baseline up to Month 36
Secondary	Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In =5% of Participants	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.	Baseline up to Month 36
Secondary	Number Of Participants With A Significant Mean Change From Baseline In Vital Signs	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.	Baseline up to Month 36
Secondary	Change From Baseline In Conn Score At Last Assessment	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.	Baseline up to Month 36