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Chronic Hepatitis C clinical trials

View clinical trials related to Chronic Hepatitis C.

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NCT ID: NCT00475176 Completed - Chronic Hepatitis C Clinical Trials

S-Adenosyl Methionine (SAMe) to Treat Patients With Chronic Hepatitis C

Start date: May 2007
Phase: Phase 2
Study type: Interventional

This study will examine the effectiveness of S-adenosyl methionine (SAMe) in combination with peginterferon and ribavirin for treating hepatitis C virus. One out of three patients with hepatitis C develops cirrhosis of the liver, which can lead to liver failure or liver cancer. SAMe is a nutritional supplement that is made naturally in all cells of the body and acts to improve how the body handles stress. In laboratory experiments with liver cells, SAMe decreases the injury caused by liver toxins and improves the ability of interferon to block hepatitis C virus. Patients 18 years of age and older with hepatitis C infection who did not respond successfully to prior treatment with interferon and ribavirin or peginterferon and ribavirin may be eligible for this study. Participants receive the following treatment: - Peginterferon (given by injection) and ribavirin (taken by mouth) for 2 weeks - Washout period (no medications) for 4 weeks - SAMe (taken by mouth) for 2 weeks - Peginterferon, ribavirin and SAMe for 12-48 weeks, depending on patient response to treatment. Participants have a thorough physical evaluation before beginning treatment and again at the study's end. After starting treatment, patients return for clinic visits and blood tests weekly for the first several weeks, then less frequently (at 2-week, then 4-week and 8-week intervals until up to 72 weeks) to monitor symptoms, drug side effects, hepatitis C virus levels, liver enzyme levels and immune responses to hepatitis C.

NCT ID: NCT00466336 Completed - Cirrhosis Clinical Trials

Prediction of Hepatic Fibrosis in Patients With Chronic Hepatitis C by Biochemical and Duplex Doppler Indices

Start date: January 2003
Phase: N/A
Study type: Observational

The purpose of our prospective study was to evaluate the value of Doppler parameters and compare the diagnostic accuracy of Doppler parameters with various biochemical indices in predicting significant hepatic fibrosis (≥ F2) and cirrhosis (F4) in chronic hepatitis C (CHC) patients.

NCT ID: NCT00466271 Completed - Chronic Hepatitis C Clinical Trials

Prediction of Significant Hepatic Fibrosis in HCV Carriers With PNALT by SAPI- A Validation Study

Start date: April 2007
Phase: N/A
Study type: Observational

The purpose of the study is to validate the diagnostic accuracy and reproducibility of SAPI to predict significant hepatic fibrosis in HCV patients with PNALT who are scheduled to receive combination therapy with pegylated interferon plus ribavirin and percutaneous liver biopsies.

NCT ID: NCT00446134 Completed - Chronic Hepatitis C Clinical Trials

Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)

Start date: March 2007
Phase: Phase 2
Study type: Interventional

The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic Hepatitis C Virus (HCV) genotype 1 infection.

NCT ID: NCT00445419 Completed - Chronic Hepatitis C Clinical Trials

Phase I Hepatitis C Vaccine Trial of Virosome-formulated Peptides

Start date: December 2006
Phase: Phase 1
Study type: Interventional

Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a hepatitis C virus infection. In-depth research in recent years has shown that the cellular immune response is even more effective when supported by helper T-cells. Pevion Biotech's HCV vaccine candidate utilizes this effect inducing specific CTL responses (PeviTER) together with a supportive helper T cell response (PeviPRO). This virosome-based technological combination in a single product represents a new generation of modular therapeutic vaccines.

NCT ID: NCT00433108 Completed - Chronic Hepatitis C Clinical Trials

Trial of MitoQ for Raised Liver Enzymes Due to Hepatitis C

Start date: March 2007
Phase: Phase 2
Study type: Interventional

A Phase 2, randomized, double-blind, parallel design trial of two doses of mitoquinone mesylate (MitoQ) and of placebo in patients with chronic Hepatitis C. MitoQ is a mitochondria-targeted antioxidant that rapidly permeates the lipid bilayer and accumulates within mitochondria in organs such as liver, brain, heart, skeletal muscle. There is strong evidence for increased oxidative stress and mitochondrial damage leading to apoptosis via caspase activation. Several studies have shown that MitoQ protects cells from apoptosis by acting as a caspase inhibitor and may be effective in reducing cell damage in liver disease. It is hypothesised that administration of MitoQ will lower raised ALT seen in patients with chronic Hepatitis C compared with placebo. Approximately 36 patients who have been unresponsive or not suitable for interferon-based therapy will be enrolled at one centre. Treatment duration will be 28 days with 28 days post-treatment follow-up.

NCT ID: NCT00433069 Completed - Chronic Hepatitis C Clinical Trials

Retreatment of Chronic Hepatitis C Non-responders With Pegylated Interferon Alpha Plus Ribavirin Plus Pioglitazone

Start date: January 2007
Phase: Phase 2
Study type: Interventional

The aim of this study is to investigate the efficacy and safety of an insulin-sensitizer (Actos) added to a standard Pegasys/Copegus combination therapy of chronic hepatitis C in patients who have previously failed a pegylated-interferon-alpha / ribavirin combination without the insulin sensitizer. The primary endpoint is the initial virological response (level of HCV RNA in serum) as evaluated after 12 weeks of triple therapy.

NCT ID: NCT00423670 Completed - Chronic Hepatitis C Clinical Trials

Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)

Start date: January 2007
Phase: Phase 2
Study type: Interventional

This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly [QW]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.

NCT ID: NCT00421434 Completed - Chronic Hepatitis C Clinical Trials

Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C

STEALTHC-1
Start date: June 2006
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C genotype 4. The study will also evaluate the effect of the studied treatment regimens on end of treatment virologic response, ALT normalization and safety parameters.

NCT ID: NCT00418639 Completed - Chronic Hepatitis C Clinical Trials

Study of Nitazoxanide in the Treatment of Chronic Hepatitis C

Start date: February 2005
Phase: Phase 2
Study type: Interventional

This study will evaluate the effect of treatment with 24 weeks nitazoxanide monotherapy on end of treatment virologic response, sustained virologic response, reduction of quantitative serum HCV RNA, changes in ALT and safety parameters.