Rifaximin for Liver Diseases

Phase-Based Estimates
3
Effectiveness
3
Safety
Valeant Site 01, San Antonio, TX
Liver Diseases+1 More
Rifaximin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Liver Diseases

Study Summary

This study is evaluating whether a drug may be safe for human consumption.

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Eligible Conditions

  • Liver Diseases
  • Severe Hepatic Impairment

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Rifaximin will improve 3 primary outcomes in patients with Liver Diseases. Measurement will happen over the course of 7 days.

7 days
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)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

Rifaximin 550 mg BID
Hepatic encephalopathy
19%
Oedema peripheral
17%
Constipation
16%
Nausea
14%
Fatigue
14%
Insomnia
12%
Urinary tract infection
11%
Pruritus generalised
10%
Muscle spasms
8%
Decreased appetite
7%
Abdominal pain
7%
Headache
6%
Ascites
6%
Dyspnoea
6%
Anxiety
5%
Cough
5%
Anaemia
5%
Renal failure acute
5%
Asthenia
5%
Vomiting
5%
Jaundice
4%
Diarrhoea
4%
Cellulitis
3%
Abdominal distension
3%
Depression
3%
Hyperkalaemia
2%
Bronchitis
2%
Liver transplant
2%
Peritonitis bacterial
2%
Upper gastrointestinal haemorrhage
1%
Cardiac failure congestive
1%
Calculus ureteric
1%
Alcoholic seizure
1%
Toxic encephalopathy
1%
Non-cardiac chest pain
1%
Renal failure
1%
Subarachnoid haemorrhage
1%
Chest pain
1%
Gastrointestinal haemorrhage
1%
Cerebrovascular accident
1%
Dehydration
1%
Haematemesis
1%
Herpes zoster
1%
Pneumonia
1%
Sepsis
1%
Suicidal ideation
1%
Pneumococcal bacteraemia
1%
Chronic hepatic failure
1%
Acute respiratory failure
1%
Systemic inflammatory response syndrome
1%
Subdural haematoma
1%
Thrombocytopenia
1%
Haematochezia
1%
Hepatitis
1%
Hepatic failure
1%
Hyperglycaemia
1%
Fluid overload
1%
Septic shock
1%
Hepatorenal syndrome
1%
Hypovolaemic shock
1%
Flatulence
1%
Craniocerebral injury
1%
Anxiety disorder
1%
Pleural effusion
1%
Oliguria
1%
Convulsion
0%
Necrotising fasciitis
0%
Dizziness
0%
Gastroenteritis
0%
Respiratory failure
0%
Hepatic cirrhosis
0%
Coagulopathy
0%
Hepatic hydrothorax
0%
Hyponatraemia
0%
Lumbar spinal stenosis
0%
Spinal claudication
0%
Acute myocardial infarction
0%
Atrial fibrillation
0%
Hypoxia
0%
Staphylococcal bacteraemia
0%
Altered state of consciousness
0%
Pulmonary hypertension
0%
Pneumothorax
0%
Diverticulitis
0%
Supraventricular tachycardia
0%
Muscular weakness
0%
Synovitis
0%
Multiple drug overdose
0%
Presyncope
0%
Incisional hernia
0%
Colon cancer
0%
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01842581) in the Rifaximin 550 mg BID ARM group. Side effects include: Hepatic encephalopathy with 19%, Oedema peripheral with 17%, Constipation with 16%, Nausea with 14%, Fatigue with 14%.

Trial Design

2 Treatment Groups

Control
Rifaximin

This trial requires 18 total participants across 2 different treatment groups

This trial involves 2 different treatments. Rifaximin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Rifaximin
Drug
Rifaximin 550 mg BID
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 7 days for reporting.

Closest Location

Valeant Site 01 - San Antonio, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Hepatically impaired subjects will be ≥18 years of age, have a diagnosis of liver cirrhosis and a MELD score of ≥19 at Screening. Note: At least 6 of the hepatically impaired subjects will have a MELD score of >25.

Patient Q&A Section

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

What is liver diseases?

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The prevalence of liver diseases in China is estimated as over 90%. Hepatitis B is the most common cause of hepatitis in Chinese population and can be effectively controlled by immunization against the virus.

Unverified Answer

What are common treatments for liver diseases?

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liver disease treatments vary according to the type of liver disease and the presence and severity of hepatic dysfunction.\n\n- Liver Disease - Overview U.S. National Library of Medicine\n- "

"Bulbophyllum brachystachyum\n\nBulbophyllum brachystachyum is a species of orchid in the genus "Bulbophyllum".

Unverified Answer

What causes liver diseases?

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The most commonly found causes of liver diseases in this study were virus infection, alcoholic liver disease, drug abuse, and other drugs. More than 90% of cirrhosis in the study was diagnosed after an infection with hepatitis B or C virus.

Unverified Answer

What are the signs of liver diseases?

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Lying abdominal pain, itch, swollen limb(s), tender spleen and tender liver(s) are the major signs due to liver diseases. Hepatomegaly (particularly in the right upper quadrant) is the most common finding. Hepatomegaly and ochre discolouration of the skin

Unverified Answer

How many people get liver diseases a year in the United States?

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In the United States more than 1.8 million adults per year have a chronic disease that was related to excessive alcohol consumption. Most of these adults were men, and many were nondrinkers or nondieters. There were no racial or ethnic differences in the chronic liver diseases or the risk factors cited by participants in the U.S. National Health and Nutrition Examination Survey (2001-2002).

Unverified Answer

Can liver diseases be cured?

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Liver diseases can be cured. The key to success lies in early diagnosis and treatment of the disease using proper therapeutic modalities, such as antibiotics and antiviral therapy. However, none of this has ever been proven in clinical trials to date and as such it remains a research area requiring further efforts.

Unverified Answer

What is the primary cause of liver diseases?

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The primary cause of hepatic degeneration are [alcohol, chronic viral infection, chronic drug, alcoholic steatohepatitis, hepatitis C, \nprimary biliary cirrhosis, \nprimary sclerosing cholangitis, \nalcoholic hepatitis, \nhyper-vitaminosis A and hepatitis B.]<br>[with]<br>[Consequences:-<br>alcoholic hepatitis can be cured and the other complications can be avoided if all patients who suffer from alcoholic hepatitis are treated. Patients with chronic viral infections like Hepatitis C and the Hepatitis B virus should be vaccinated at the earliest feasible day.

Unverified Answer

Have there been any new discoveries for treating liver diseases?

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Treatment with pentoxifylline has been shown to have some positive effects to ameliorate liver damage in chronic liver disease, and the role of pentoxifylline needs to be further explored. Antioxidant therapies might produce promising results in the potential of liver diseases, and further experimentation is needed.

Unverified Answer

How serious can liver diseases be?

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Liver diseases can be so serious, and in serious cases, it needs immediate medical consultation or referral. The serious liver diseases are [hepatitis B virus (HBV) reactivation, HBV-ACL] (when you are being treated with anti-HCV therapies like PEG-IFN, ribavirin, etc.

Unverified Answer

Has rifaximin proven to be more effective than a placebo?

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Rifaximin was found to be more effective than placebo to reduce stools in patients with active idiopathic non-biliary spasm. Rifaximin's effectiveness was equivalent to antibiotics. Further studies must be conducted to further evaluate the treatment's efficacy.

Unverified Answer

What is the average age someone gets liver diseases?

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The liver is the central organ of metabolizing and excreting ingested lipids and carbohydrates. In general, when the liver is no longer able to process them, that condition generally arises when the child reaches the age 12 years (5 years after the age of first-time exposure to an identifiable cause). Liver diseases can begin to appear later if people are more severely exposed to toxins such as inorganic hepatocarcinogens, environmental tobacco smoke (e.g. carbon tetrachloride, a gasoline additive), alcohol, or heavy metals accumulating in tissues: the process has usually proceeded for about 15 years when it becomes clinically obvious.

Unverified Answer

What are the latest developments in rifaximin for therapeutic use?

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Rifaximin has good tolerability, the best absorption of pectin-degrading enzymes, the ability to cross the epithelial mucosal barrier, and good in vivo activity by the oral route. Rifaximin might be considered as a therapy for intestinal infections, metabolic diseases, and inflammatory bowel diseases.

Unverified Answer
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