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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: NCT00823342 Terminated - Clinical trials for Hepatitis B Viral Infection

ANRS HB 05 Multicenter Study Evaluating Efficacy and Safety of Clevudine Monotherapy Versus Tenofovir Monotherapy Versus Combination Therapy of Clevudine and Tenofovir for 96 Weeks in HBeAg Negative Patients With Chronic Hepatitis B, naïve to Anti-VHB Therapy

Start date: December 14, 2008
Phase: Phase 3
Study type: Interventional

For chronic HBV infection, an optimal pharmacological agent to promote recovery from chronic HBV infection would be one that inhibits HBV DNA polymerase, combined with the clearence from the liver of cccDNA to block HBV reactivation after the circulating viral burden has been eliminated by therapy. The activity of clevudine on cccDNA in combination with its potent antiviral activity on HBV polymerase makes it the optimal agent in combination with tenofovir for this protocol.

NCT ID: NCT00811967 Terminated - Liver Cirrhosis Clinical Trials

Inhibition of Disease Progression in Hepatitis C-infected Patients With Compensated Liver Cirrhosis (P03811) (COMPLETED)

Start date: February 2003
Phase: Phase 3
Study type: Interventional

The objective of the study is to evaluate the superiority of treatment with PegIntron and Rebetol over no antiviral therapy (control group) in subjects with chronic hepatitis C and type C compensated cirrhosis. Subjects will be randomized in a ratio of 2:1 (Treatment Arm to Control Arm). Subjects in the Treatment Arm will receive combination therapy with PegIntron and Rebetol for 48 weeks; then will enter a 24-week post-treatment Follow-up. Subjects who have detectable Hepatitis C Virus-RNA at Treatment Week 24 will discontinue treatment and enter Follow-up.

NCT ID: NCT00810875 Terminated - Hepatitis C Clinical Trials

Study of Maternal Hepatitis C Infection and Influenza Vaccination in Pregnancy

Start date: April 2009
Phase: N/A
Study type: Observational

The purpose of this study is to determine if hepatitis C virus and influenza virus vaccine components can cross the placenta and stimulate an immune response in the fetus.

NCT ID: NCT00803309 Terminated - Clinical trials for Hepatitis C, Chronic

Study to Assess the Efficacy of 12 Versus 24 Weeks of Extended Treatment in HCV-Genotype 2/3 Patients

OPTEX2/3
Start date: November 2008
Phase: Phase 4
Study type: Interventional

In this study we intend to treat patients with chronic hepatitis C of genotype 2 or 3 having characteristics associated with poor treatment response for additional 12 or 24 weeks beyond the standard treatment of PEG-IFN alpha-2b plus ribavirin. The objective of this study is to compare the efficacy of a treatment extension of 12 versus 24 weeks in patients with HCV-genotypes 2 and 3 who are treated with 1.5 µg/kg PEG-IFN alpha-2b and 800-1400 mg ribavirin (standard dose) for 24 weeks (standard duration) and who are not HCV-RNA negative (< 15 IU/ml) after 4 weeks of standard treatment but HCV-RNA negative after 16-24 weeks of standard treatment.

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: NCT00798460 Terminated - Chronic Hepatitis B Clinical Trials

Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients

Start date: December 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the optimal antiviral treatment for lamivudine resistant hepatitis B patients.

NCT ID: NCT00768001 Terminated - Hepatitis C Clinical Trials

Genetic Analysis of Liver Cancer

Start date: June 2008
Phase: N/A
Study type: Observational

Liver cancer is a leading cause of cancer deaths worldwide. While the molecular pathogenesis of liver cancer has been extensively studied, less is known about how the molecular biology of liver cancer influences clinical outcome and treatment response. We are developing a translational research program that will characterize molecular changes in liver cancer. We plan to use molecular information obtained from studying liver tumor tissues to develop new diagnostics and treatment regimens for patients with these cancers. The experimental approach will require freezing fresh tumor tissues obtained from surgical procedures, which will be subsequently used for analysis of DNA, protein and mRNA expression. Many patients with liver cancer are referred to the Stanford Liver Tumor Board for consultation and treatment recommendations. We propose to gather tissue samples from those who subsequently undergo biopsy, liver resection surgery, or transplant surgery.

NCT ID: NCT00767936 Terminated - Hepatitis C Clinical Trials

Viral & Host Factors Associated With Hepatitis B Virus-related Hepatocellular Carcinoma

Start date: March 2008
Phase: N/A
Study type: Observational

Adult liver cancer is the third leading cause of cancer deaths worldwide. The major risk factor for liver cancer is hepatitis B virus (HBV) infection. The purpose of the study is to sequence the HBV genome in patients with chronic HBV infection, and in patients with liver cancer resulting from chronic HBV infection. The goal is to identify mutations in the HBV genome that predisposes these high risk individuals to the development of liver cancer.