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Antibiotic

Rifaximin for Liver Damage

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 7 days
Awards & highlights

Study Summary

This trial is studying how a drug affects the body over time.

Eligible Conditions
  • Severe Liver Damage

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration Versus Time Curve (AUC) During the 12-hour Dose Interval
Maximum Observed Plasma Concentration (Cmax)
Time of the Maximum Concentration (Tmax)

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

1Treatment groups
Experimental Treatment
Group I: RifaximinExperimental Treatment1 Intervention
Rifaximin 550 mg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin
FDA approved

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
82,023 Total Patients Enrolled
Lindsey MathewStudy DirectorBausch Health Companies
17 Previous Clinical Trials
5,873 Total Patients Enrolled
Varsha BhattStudy DirectorBausch Health Companies
8 Previous Clinical Trials
1,034 Total Patients Enrolled

Frequently Asked Questions

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

What risk factors should be considered when administering Rifaximin to patients?

"The safety of rifaximin has been verified through extensive clinical trials and is therefore assigned a score of 3."

Answered by AI

What is the aggregate quantity of participants signed up for this experiment?

"Affirmative. According to information found on clinicaltrials.gov, this medical trial was initially posted in December 2018 and is currently recruiting participants. The programme necessitates 18 patients from one specific site."

Answered by AI

Is recruitment currently open for this clinical investigation?

"Affirmative. According to clinicaltrials.gov, recruitment is ongoing for this study which was established on December 5th 2018 and updated as recently as September 7th 2022. 18 individuals need to be enrolled at 1 site in order to complete the trial's requirements."

Answered by AI

What conditions are typically addressed with Rifaximin treatments?

"Rifaximin is frequently prescribed to prevent relapses of clostridium difficile infection, but can also be used to treat Irritable Bowel Syndrome (IBS), bacterial infections, and diarrhea."

Answered by AI
~1 spots leftby Mar 2025