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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
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 5 Other Conditions
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial studies how rifaximin behaves in people with severe liver problems. The medication helps by targeting bacteria in the intestines, which can be beneficial for those with liver issues. Rifaximin has been used for prevention of recurrence of hepatic encephalopathy.
Eligible Conditions
- Severe Liver Damage
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 • NCT0184258119%
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%
Hyperkalaemia
2%
Bronchitis
2%
Peritonitis bacterial
2%
Liver transplant
1%
Gastrointestinal haemorrhage
1%
Haematemesis
1%
Non-cardiac chest pain
1%
Pneumonia
1%
Sepsis
1%
Fluid overload
1%
Hyperglycaemia
1%
Acute respiratory failure
1%
Herpes zoster
1%
Cerebrovascular accident
1%
Thrombocytopenia
1%
Pneumococcal bacteraemia
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
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
82,031 Total Patients Enrolled
Varsha BhattStudy DirectorBausch Health Companies
8 Previous Clinical Trials
1,034 Total Patients Enrolled
Lindsey MathewStudy DirectorBausch Health Companies
17 Previous Clinical Trials
5,873 Total Patients Enrolled
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