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Antibiotic

Rifaximin for Encephalopathy

Phase 4
Waitlist Available
Research Sponsored by Bausch Health Americas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will study the safety of Rifaximin, a drug used to treat hepatic encephalopathy, in subjects with severe liver impairment.

Eligible Conditions
  • Liver Encephalopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode
Secondary outcome measures
Proportion of Participants With HE-related Hospitalization
Other outcome measures
Adverse Events
Assessment of Quality of Life
Electrocardiograms (12 lead ECG findings)
+4 more

Side effects data

From 2014 Phase 4 trial • 222 Patients • NCT01842581
19%
Hepatic encephalopathy
17%
Oedema peripheral
16%
Constipation
14%
Nausea
14%
Fatigue
12%
Insomnia
11%
Urinary tract infection
10%
Pruritus generalised
8%
Muscle spasms
7%
Abdominal pain
7%
Decreased appetite
6%
Ascites
6%
Dyspnoea
6%
Headache
5%
Cough
5%
Renal failure acute
5%
Vomiting
5%
Asthenia
5%
Anaemia
5%
Anxiety
4%
Jaundice
4%
Diarrhoea
3%
Abdominal distension
3%
Cellulitis
3%
Depression
2%
Bronchitis
2%
Peritonitis bacterial
2%
Hyperkalaemia
2%
Liver transplant
1%
Acute respiratory failure
1%
Gastrointestinal haemorrhage
1%
Fluid overload
1%
Hyperglycaemia
1%
Non-cardiac chest pain
1%
Haematemesis
1%
Herpes zoster
1%
Cerebrovascular accident
1%
Thrombocytopenia
1%
Pneumococcal bacteraemia
1%
Pneumonia
1%
Sepsis
1%
Septic shock
1%
Craniocerebral injury
1%
Hepatic failure
1%
Hepatitis
1%
Hepatorenal syndrome
1%
Toxic encephalopathy
1%
Subarachnoid haemorrhage
1%
Anxiety disorder
1%
Suicidal ideation
1%
Calculus ureteric
1%
Oliguria
1%
Renal failure
1%
Pleural effusion
1%
Flatulence
1%
Cardiac failure congestive
1%
Haematochezia
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
Systemic inflammatory response syndrome
1%
Chronic hepatic failure
1%
Subdural haematoma
1%
Dehydration
1%
Alcoholic seizure
1%
Hypovolaemic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rifaximin 550 mg BID
Rifaximin 550 mg BID + Lactulose

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RifaximinExperimental Treatment1 Intervention
Rifaximin, oral, 550 mg BID, 6 months of treatment
Group II: PlaceboPlacebo Group1 Intervention
Placebo, oral, 0 mg BID, 6 months of treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin
2005
Completed Phase 4
~3120

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
82,022 Total Patients Enrolled
Enoch Bortey, Ph.D.Study DirectorBausch Health Americas, Inc.
Varsha Bhatt, Ph.D.Study DirectorBausch Health Americas, Inc.

Media Library

Rifaximin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT01846663 — Phase 4
Encephalopathy Research Study Groups: Placebo, Rifaximin
Encephalopathy Clinical Trial 2023: Rifaximin Highlights & Side Effects. Trial Name: NCT01846663 — Phase 4
Rifaximin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01846663 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a precedent of research involving Rifaximin?

"Rifaximin was first investigated in 2009 at the New mexico VA Healthcare System, and since then has seen 18,374 completed trials. At present there are 23 separate active studies being conducted primarily from La Jolla, California."

Answered by AI

Are there any vacancies remaining in this clinical trial?

"Affirmative. The clinical trial data hosted on clinicialtrials.gov attests to the fact that this medical research has been actively recruiting since it was first posted in April 2013, and most recently updated in September 2022. 100 participants need to be enrolled from 23 separate sites."

Answered by AI

How extensively has this clinical trial been disseminated across the state?

"At the moment, 23 trial sites are recruiting patients for this clinical study. These locations include La Jolla, Chicago and Rialto as well as 20 other spots across the country. To make participation easier on you, it is wise to pick a location proximate to your home in order to reduce any transportation costs that may arise."

Answered by AI

What is the total enrollment capacity of this trial?

"Affirmative. According to clinicaltrials.gov, the study that was initially published on April 3rd 2013 is presently seeking participants. One hundred individuals must be recruited across 23 medical facilities for this trial to move forward."

Answered by AI

What ailments is Rifaximin prescribed for?

"Rifaximin is usually utilized to treat recurrences of clostridium difficile infections. Additionally, it can be prescribed for bacterial infections, diarrhea and irritable bowel syndrome (IBS)."

Answered by AI

Are there any adverse effects associated with using Rifaximin?

"Prior studies have indicated that Rifaximin is safe, so the Power team gave it a 3 out of 3 rating. This drug has already been approved for consumer use by relevant regulatory bodies."

Answered by AI
~1 spots leftby Mar 2025