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HEPATIC FAILURE and RIBASPHERE

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HEPATIC FAILURE Symptoms and Causes

What is fatty liver disease?

Your liver is the largest organ inside your body. It helps your body digest food, store energy, and remove poisons. Fatty liver disease is a condition in which fat builds up in your liver. There are two main types:

  • Nonalcoholic fatty liver disease (NAFLD)
  • Alcoholic fatty liver disease, also called alcoholic steatohepatitis
What is nonalcoholic fatty liver disease (NAFLD)?

NAFLD is a type of fatty liver disease that is not related to heavy alcohol use. There are two kinds:

  • Simple fatty liver, in which you have fat in your liver but little or no inflammation or liver cell damage. Simple fatty liver typically does not get bad enough to cause liver damage or complications.
  • Nonalcoholic steatohepatitis (NASH), in which you have inflammation and liver cell damage, as well as fat in your liver. Inflammation and liver cell damage can cause fibrosis, or scarring, of the liver. NASH may lead to cirrhosis or liver cancer.
What is alcoholic fatty liver disease?

Alcoholic fatty liver disease is due to heavy alcohol use. Your liver breaks down most of the alcohol you drink, so it can be removed from your body. But the process of breaking it down can generate harmful substances. These substances can damage liver cells, promote inflammation, and weaken your body's natural defenses. The more alcohol that you drink, the more you damage your liver. Alcoholic fatty liver disease is the earliest stage of alcohol-related liver disease. The next stages are alcoholic hepatitis and cirrhosis.

Who is at risk for fatty liver disease?

Researchers do not know the cause of nonalcoholic fatty liver (NAFLD). They do know that it is more common in people who

  • Have type 2 diabetes and prediabetes
  • Have obesity
  • Are middle aged or older (although children can also get it)
  • Are Hispanic, followed by non-Hispanic whites. It is less common in African Americans.
  • Have high levels of fats in the blood, such as cholesterol and triglycerides
  • Have high blood pressure
  • Take certain drugs, such as corticosteroids and some cancer drugs
  • Have certain metabolic disorders, including metabolic syndrome
  • Have rapid weight loss
  • Have certain infections, such as hepatitis C
  • Have been exposed to some toxins

NAFLD affects about 25 percent of people in the world. As the rates of obesity, type 2 diabetes, and high cholesterol are rising in the United States, so is the rate of NAFLD. NAFLD is the most common chronic liver disorder in the United States.

Alcoholic fatty liver disease only happens in people who are heavy drinkers, especially those who have been drinking for a long period of time. The risk is higher for heavy drinkers who are women, have obesity, or have certain genetic mutations.

What are the symptoms of fatty liver disease?

Both NAFLD and alcoholic fatty liver disease are usually silent diseases with few or no symptoms. If you do have symptoms, you may feel tired or have discomfort in the upper right side of your abdomen.

How is fatty liver disease diagnosed?

Because there are often no symptoms, it is not easy to find fatty liver disease. Your doctor may suspect that you have it if you get abnormal results on liver tests that you had for other reasons. To make a diagnosis, your doctor will use

  • Your medical history
  • A physical exam
  • Various tests, including blood and imaging tests, and sometimes a biopsy

As part of the medical history, your doctor will ask about your alcohol use, to find out whether fat in your liver is a sign of alcoholic fatty liver disease or nonalcoholic fatty liver (NAFLD). He or she will also ask which medicines you take, to try to determine whether a medicine is causing your NAFLD.

During the physical exam, your doctor will examine your body and check your weight and height. Your doctor will look for signs of fatty liver disease, such as

  • An enlarged liver
  • Signs of cirrhosis, such as jaundice, a condition that causes your skin and whites of your eyes to turn yellow

You will likely have blood tests, including liver function tests and blood count tests. In some cases you may also have imaging tests, like those that check for fat in the liver and the stiffness of your liver. Liver stiffness can mean fibrosis, which is scarring of the liver. In some cases you may also need a liver biopsy to confirm the diagnosis, and to check how bad the liver damage is.

What are the treatments for fatty liver disease?

Doctors recommend weight loss for nonalcoholic fatty liver. Weight loss can reduce fat in the liver, inflammation, and fibrosis. If your doctor thinks that a certain medicine is the cause of your NAFLD, you should stop taking that medicine. But check with your doctor before stopping the medicine. You may need to get off the medicine gradually, and you might need to switch to another medicine instead.

There are no medicines that have been approved to treat NAFLD. Studies are investigating whether a certain diabetes medicine or Vitamin E can help, but more studies are needed.

The most important part of treating alcohol-related fatty liver disease is to stop drinking alcohol. If you need help doing that, you may want to see a therapist or participate in an alcohol recovery program. There are also medicines that can help, either by reducing your cravings or making you feel sick if you drink alcohol.

Both alcoholic fatty liver disease and one type of nonalcoholic fatty liver disease (nonalcoholic steatohepatitis) can lead to cirrhosis. Doctors can treat the health problems caused by cirrhosis with medicines, operations, and other medical procedures. If the cirrhosis leads to liver failure, you may need a liver transplant.

What are some lifestyle changes that can help with fatty liver disease?

If you have any of the types of fatty liver disease, there are some lifestyle changes that can help:

  • Eat a healthy diet, limiting salt and sugar, plus eating lots of fruits, vegetables, and whole grains
  • Get vaccinations for hepatitis A and B, the flu and pneumococcal disease. If you get hepatitis A or B along with fatty liver, it is more likely to lead to liver failure. People with chronic liver disease are more likely to get infections, so the other two vaccinations are also important.
  • Get regular exercise, which can help you lose weight and reduce fat in the liver
  • Talk with your doctor before using dietary supplements, such as vitamins, or any complementary or alternative medicines or medical practices. Some herbal remedies can damage your liver.

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RIBASPHERE Side Effects

Fatigue (131)
Anaemia (129)
Depression (100)
Asthenia (95)
Dyspnoea (84)
Nausea (82)
Dizziness (67)
White Blood Cell Count Decreased (63)
Dehydration (62)
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HEPATIC FAILURE Clinical Trials and Studies

Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses. People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.
Rank Status Study
1 Unknown  Ribavirin Pre-treatment Followed by Combined Standard Therapy in Hepatitis C Virus (HCV) Recipients
Condition: Hepatitis C
Intervention: Drug: ribavirin pre-treatment
Outcome Measures: HCV-RNA level, Transaminases level;   liver biopsy and Transient elastography at baseline and after six month since therapy conclusion
2 Recruiting Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1)
Condition: Hepatitis C
Interventions: Drug: A: Peg-interferon alpha-2a & Ribavirin;   Drug: B: Peg-interferon alpha-2a & Ribavirin;   Drug: C: Peg-interferon alpha-2a & Ribavirin;   Drug: D: Peg-interferon alpha-2a & Ribavirin;   Drug: E: Peg-interferon alpha-2a & Ribavirin;   Drug: F: Peg-interferon alpha-2a & Ribavirin
Outcome Measures: Efficacy;   Safety
3 Recruiting In Hepatitis C Patients Treated With Interferon and Ribavirin, Does Hepcidin Contribute to Treatment Induced Anaemia
Condition: Hepatitis C
Interventions: Drug: Pegylated interferon alpha;   Drug: Ribavirin
Outcome Measures: Hepcidin levels;   iron metabolism markers;   heamolysis markers;   inosine triphosphatase genetic variants;   erythropoiesis markers
4 Unknown  RIBAJUSTE Clinical Trial Investigating the Efficacy and Safety of Dose Adaptation of Ribavirin
Condition: Chronic Hepatitis C
Interventions: Drug: Peg-interferon alpha 2a and ribavin;   Drug: ribavirin with adaptation dose
Outcome Measures: Inter-group comparison of sustained virological response rates as defined by the proportion of subjects with a negative PCR HCV-RNA test at Week 72;   Efficacy endpoints;   safety endpoints;   Economic endpoints
5 Recruiting Induction Chemotherapy With Afatinib, Ribavirin, and Weekly Carboplatin/Paclitaxel for Stage IVA/IVB HPV Associated Oropharynx Squamous Cell Cancer (OPSCC)
Conditions: Head and Neck Cancer;   Squamous Cell Cancer
Intervention: Drug: Afatinib, Ribavirin, and weekly carboplatin/paclitaxel
Outcome Measures: maximum tolerated dose (For Dose Escalation Portion of the study);   expression of PTPN13 (For Expansion Cohort only);   safety and tolerability (toxicity);   objective response rate;   pharmacokinetics
6 Recruiting Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO)
Condition: Hepatitis C Virus Genotype 4 Infection
Interventions: Drug: Asunaprevir;   Drug: Daclatasvir;   Drug: Ribavirin;   Drug: Pegylated Interferon alpha-2a
Outcome Measures: SVR12 Rate;   Number of patients with adverse events;   Treatment discontinuations;   Self-reported symptoms;   Patients' adherence;   SVR 24 rate;   HCV viral load;   Number of patients with virological failure under treatment;   HCV subtypic distribution;   Proportion of patients with resistance mutations to Asunaprevir and/or Daclatasvir in case of virological failure;   Cirrhosis evaluation;   Insulin resistance : HOMA-IR score;   Metabolic syndrome parameters;   Liver fibrosis;   Polymorphism of the gene of IL28B
7 Recruiting Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
Condition: Hepatitis C
Interventions: Biological: Pegylated Interferon Lambda;   Drug: Ribasphere;   Drug: Daclatasvir
Outcome Measures: Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected;   Proportion of non-cirrhotic HCV GT-1b subjects with eRVR, defined as HCV RNA < LLOQ target not detected;   Proportion of non-cirrhotic HCV GT-1b subjects with treatment-emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3, and/or thrombocytopenia as defined by platelets < 50,000 mm3) on treatment;   Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated flu-like symptoms (pyrexia or chills or pain);   Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated musculoskeletal symptoms (arthralgia or myalgia or back pain);   Proportion of non-cirrhotic HCV GT-1b subjects with SVR24, defined as HCV RNA < LLOQ target detected or not detected;   Frequency of deaths among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks);   Frequency of Serious adverse events (SAEs) among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks);   Frequency of drug related Adverse events (AEs) among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks);   Frequency of dose reductions and discontinuations due to AEs among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks);   Frequency of treatment emergent laboratory abnormalities among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks);   Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated constitutional symptoms (fatigue or asthenia) through the end of treatment (maximum of 12 weeks);   Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated neurologic symptoms (headache or dizziness) through the end of treatment (maximum of 12 weeks);   Proportion of non-cirrhotic HCV GT-1b subjects with psychiatric symptoms (depression or irritability or insomnia) through the end of treatment (maximum of 12 weeks)
8 Recruiting Boceprevir/PegIFN α-2b/Riba in HCV+ Gt1 Menopausal Women, Nonresponders to PegIFN/Riba or Treatment-naives (MEN_BOC)
Conditions: Chronic Hepatitis C;   Menopause
Intervention: Drug: Pegylated Interferon, Ribavirin, Boceprevir
Outcome Measures: Improvement of sustained virological response in previous treatment failure or naive HCV-positive menopausal women.;   Early virological response
9 Recruiting Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C, Chronic
Interventions: Drug: Miravirsen;   Drug: Telaprevir;   Drug: Ribavirin
Outcome Measures: The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.;   The proportion of subjects with undetectable HCV RNA levels at end of treatment.;   The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.;   Change in HCV RNA levels from baseline throughout the study.;   The proportion of subjects who experience virological failure throughout the study.
10 Not yet recruiting A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
Conditions: Chronic Hepatitis C;   End Stage Renal Disease
Interventions: Drug: Ribavirin;   Drug: Peginterferon;   Drug: Boceprevir
Outcome Measures: Percentage of patients who achieve eRVR at treatment week 28;   Tolerability of treatment
11 Recruiting Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C Virus
Intervention: Drug: ribavirin
Outcome Measures: ribavirin AUC-12 variability;   safety - absolute hemoglobin declines;   efficacy - early and sustained virologic response
12 Unknown  Drug Interaction Study With Ribavirin and Abacavir in Male Subjects With Hepatitis C Who Have Failed Ribavirin Treatment
Condition: Hepatitis C
Interventions: Other: Ribavrin;   Drug: Abacavir plus Ribavirin
Outcome Measures: To evaluate the effect of abacavir (ABC) on Ribavirin Triphosphate (RBV-TP) intracellular concentrations.;   To evaluate the effect of ABC on plasma RBV trough concentrations.
13 Unknown  Four Arms, Multicenter Study of Tailored Regimens With Peginterferon Plus Ribavirin for Genotype 2 Chronic Hepatitis C
Condition: Chronic Hepatitis C
Interventions: Drug: pegylated interferon alpha 2a and plus ribavirin;   Drug: Pegylated interferon alfa-2a and ribavirin;   Drug: pegylated interferon alpha 2a and ribavirin
Outcome Measures: Efficacy - Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period;   Safety - adverse event rate and profile
14 Recruiting A Study to Evaluate the Safety, Tolerability, and Effectiveness of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Patients Infected With Chronic Genotype 1 Hepatitis C Virus
Condition: Chronic Hepatitis C
Interventions: Drug: TMC647055;   Drug: TMC435;   Drug: Ritonavir;   Drug: Ribavirin;   Drug: Pegylated interferon alpha-2a (PegIFN);   Drug: GSK2336805
Outcome Measures: Number of patients with a sustained virologic response (SVR) 12 Weeks after the actual end of treatment;   Number of patients with adverse events;   Number of patients with a sustained virological response (SVR at 4 and/or 24 Weeks after the actual end of treatment);   HCV RNA levels over time;   Number of patients with undetectable hepatitis C virus (HCV) RNA (less than 25 IU/mL undetectable) and/or HCV RNA levels less than 25 IU/mL at all time points;   Number of patients with on-treatment virologic failure;   Number of patients with viral relapse;   Number of patients with presence of HCV variants associated with reduced susceptibility to investigational treatment;   Maximum plasma analyte concentration of TMC435;   Minimum plasma analyte concentration of TMC435;   Area under the plasma concentration-time curve of TMC435;   Maximum plasma analyte concentration of TMC647055;   Minimum plasma analyte concentration of TMC647055;   Area under the plasma concentration-time curve of TMC647055;   Maximum plasma analyte concentration of ritonavir (RTV);   Minimum plasma analyte concentration of RTV;   Area under the plasma concentration-time curve of RTV;   Minimum and maximum plasma concentrations of GSK233680k;   Area under the plasma concentration-time curve of GSK233680k
15 Unknown  Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Malignancy Other Than Hepatocellular Carcinoma
Conditions: Chronic Hepatitis C;   Neoplasms
Intervention: Drug: pegylated interferon alpha 2a and plus ribavirin
Outcome Measures: Efficacy - Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period.;   Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4.;   Early virological response (EVR), by PCR-negative or at least 2 logs decline from baseline of serum HCV RNA at 12 weeks of treatment.;   Safety - adverse event rate and profile
16 Unknown  Phase I/II Study of Ribavirin Given as Monotherapy in Solid Tumour Cancer Patients
Condition: Malignant Solid Tumour
Intervention: Drug: Ribavirin
Outcome Measures: Phase I: Maximum Tolerated Dose (MTD) and/or recommended phase II dose (RP2D);   Phase II: Determine the overall response rate to therapy with ribavirin;   Incidence and nature of DLTs;   Incidence, nature and severity of adverse events;   Time to and duration of response, defined as the first occurence of documented objective response until the time of recurrence or death from any cause;   Clinical benefit rate, defined as the overall response rate and stable disease for greater than or equal to 24 weeks;   Pharmacokinetic parameters of ribavirin determine by total exposure, maximum plasma concentration, etc.;   Correlation between eIF4E activity and response;   To determine the effect of ribavirin on the activity of eIF4E related pathways through correlative studies
17 Unknown  Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve Sustained Virologic Response (SVR) in Genotype 2, 3 Chronic Hepatitis C Patients?
Condition: Chronic Hepatitis C
Interventions: Drug: Peg + Vitamin D + Ribavirin;   Drug: Peg + Ribavirin
Outcome Measure: sustained virologic response (SVR)rate
18 Recruiting An Open Label Trial of Pegylated Interferon, Ribavirin and Telaprevir Versus Pegylated Interferon and Ribavirin Alone in the Treatment of Hepatitis C Genotype 1 Virus Infection in Patients With HIV-1 Co-infection
Condition: HIV
Interventions: Drug: Ribavirin;   Drug: Telaprevir
Outcome Measure: • Comparison of rates of sustained virologic response(SVR24) between treatment arms; defined as HCV RNA not detectable at 24 weeks after planned completion of therapy
19 Unknown  Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies
Condition: Hemoglobinopathies
Intervention: Drug: PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin
Outcome Measures: A sustained virological response (SVR), defined as absence of HCV RNA in serum by a highly sensitive test at the end of treatment and 6 months late.;   Early virological response (EVR) , defined as the loss of HCV RNA during the first 12 weeks of therapy; main side effects enclosing changes in blood transfusion requirement; increase in ferritin levels and variations in chelation treatment
20 Unknown  Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients
Condition: Chronic Hepatitis C
Interventions: Drug: ribavirin;   Drug: Peginterferon alfa-2a;   Drug: epoetin beta
Outcome Measure: % patients with RNA-HCV < 50 UI/ml