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Chronic Hepatitis C clinical trials

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NCT ID: NCT00844272 Completed - Chronic Hepatitis C Clinical Trials

Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment

Permit
Start date: May 2005
Phase: Phase 4
Study type: Interventional

Study objective: Feasibility and efficacy of a standardised psychosocial intervention (psychoeducation) in substituted opioid dependent patients

NCT ID: NCT00843076 Terminated - Chronic Hepatitis C Clinical Trials

Impact of Hepatitis C Virus Variability on Steatosis

Viro-steatosis
Start date: January 2009
Phase: N/A
Study type: Observational

Chronic infection by the hepatitis C virus (HCV) is a common cause of liver disease, which may progress to cirrhosis and eventually liver cancer. The therapeutic indication will depend mainly on the importance of liver damage (fibrosis), which can be assessed by physical techniques, blood tests and a liver biopsy. The overall objectives of the project are to understand how HCV variability may influence the severity of steatosis (accumulation of fat in the liver), studying 30 patients chronically infected with HCV (half of these patients infected by HCV genotype 3, versus the other half infected by HCV of another genotype). A small portion of the biopsy performed for the routine pathology examination will be placed in special fixation buffer for electron microscopy (EM). Counting and measuring the size of lipid droplets present in the liver by EM will be used to precisely quantify and characterize the liver steatosis. A blood sample of patients will also be collected to sequence the viral genome present in the patient and identify the amino acids involved in an increase in intracellular accumulation of lipid droplets. This work should clarify the impact of the viral variability in the severity of steatosis. Ultimately, the identification of viral sequences responsible for an increase of this phenomenon could be crucial for understanding the mechanisms involved in the steatosis.

NCT ID: NCT00840489 Terminated - Chronic Hepatitis C Clinical Trials

Efficacy of Long-term Ribavirin in Non-responders With Chronic Hepatitis C and Advanced Fibrosis

RIBACIR
Start date: January 2009
Phase: Phase 2
Study type: Interventional

The rate of sustained virological response to a course of standard antiviral therapy (peg-interferon plus ribavirin) of patients with chronic hepatitis C infected by genotype 1 with advanced fibrosis (>F2) is rather low. Monotherapy with ribavirin reduces ALT levels and necroinflammatory liver activity in up to a half of non-responders to standard antiviral therapy, but without changes in liver fibrosis or viremia. Such a beneficial effect seems to be mainly due to the immunomodulatory effect of ribavirin. Portal pressure, as measured by HVPG, lowers in patients with chronic hepatitis C and advanced fibrosis with end-of-treatment response to peg-interferon plus ribavirin. Portal pressure reduction in this setting relates to a reduction of the necroinflammatory liver activity, but not with fibrosis amelioration. We hypothesize that monotherapy with ribavirin reduces portal pressure in hepatitis C patients with advanced fibrosis by means of its immunomodulatory and anti-inflammatory effects, and could constitute an alternative to non-responders to standard antiviral treatment. Portal pressure measurement has become a validated surrogate outcome measure in chronic liver disease, since decreasing portal pressure has shown consistent improvement in survival and clinical outcomes, such as complications of portal hypertension. The primary aim of this study is to investigate whether ribavirin monotherapy slows the progression of advanced chronic liver disease by hepatitis C as assessed by a reduction in HVPG.

NCT ID: NCT00834860 Unknown status - Clinical trials for Hepatocellular Carcinoma

Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Hepatocellular Carcinoma

Start date: January 2007
Phase: Phase 4
Study type: Interventional

Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its impact on the outcome in chronic hepatitis C patients concomitant with hepatocellular carcinoma deserve to be elucidated. The purposes of this study are: 1. To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with hepatocellular carcinoma. 2. To investigate the role of baseline and on-treatment factors on the response to pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with hepatocellular carcinoma.

NCT ID: NCT00830609 Completed - Chronic Hepatitis C Clinical Trials

High Dose Versus Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3

DARGEN-3
Start date: November 2008
Phase: Phase 4
Study type: Interventional

The rate of sustained virological response (SVR) in patients with chronic hepatitis C, genotype 3, high viral load and without rapid virological response (RNA-HCV negative at week 4) is low. Standard of care of these patients include treatment with weekly peginterferon plus 800 mg/day of ribavirin (RBV). Extended treatment to 48 weeks does not provide more clinical benefit than the standard duration. The main hypothesis is that higher dose of ribavirin may be better in terms of SVR than the standard dose.

NCT ID: NCT00828269 Completed - Chronic Hepatitis C Clinical Trials

Evaluation of RNA From the Liver Tissue Obtained in Patients With Chronic Hepatitis C (0000-123)

Start date: April 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the quality of the RNA and the reproducibility of gene expression profiling from liver tissue samples obtained by fine needle aspiration.

NCT ID: NCT00823862 Completed - Chronic Hepatitis C Clinical Trials

Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

Start date: October 2008
Phase: Phase 1
Study type: Interventional

To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101 alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.

NCT ID: NCT00804752 Recruiting - Chronic Hepatitis C Clinical Trials

Vitamin D Treatment in Patients With Chronic Hepatitis C

Start date: n/a
Phase: N/A
Study type: Interventional

We hypothesize that patients with Ch.HCV have a low level of vitamin D, and that by raising their vitamin D levels by adding it to their standard treament of Pegylated Interferon and Ribavirin, there will be an increase in their sustained virological response.

NCT ID: NCT00800007 Terminated - Chronic Hepatitis C Clinical Trials

Study of Safety and Tolerability of Multiple Intravenous Doses of ANZ-521 in Adults With Chronic Hepatitis C Virus

Start date: November 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, immunogenicity, and antiviral effects of multiple intravenous doses of ANZ-521 in patients with chronic Hepatitis C virus.

NCT ID: NCT00790673 Completed - Chronic Hepatitis C Clinical Trials

A Phase 1/2 Study of CF102 in Patients With Chronic Hepatitis C Genotype 1

Start date: July 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This trial will test the hypothesis that CF102 can safely and effectively suppress viral load in patients with chronic hepatitis C and high circulating levels of virus. The trial will monitor the safety of twice-daily oral dosing with CF102 over a 16-week period; will measure changes in viral load during therapy; and will measure blood concentrations of CF102 at various time points during dosing.