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Hepatitis C, Chronic clinical trials

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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: NCT00441584 Terminated - Clinical trials for Hepatitis C, Chronic

The Effects of PegIntron Plus Rebetol in Subjects With Chronic Hepatitis C Not Responding to Pegasys (Study P03833)

Start date: July 2005
Phase: Phase 3
Study type: Interventional

This is an uncontrolled, non-randomized, open-label, multinational study designed to evaluate the efficacy and safety of PegIntron plus Rebetol in subjects with chronic hepatitis C. The study is designed to determine the proportion of chronic hepatitis C genotype 1 subjects who did not respond to previous treatment with Pegasys 180µg QW plus ribavirin, that will achieve sustained virological response (SVR) when treated with PegIntron plus Rebetol.

NCT ID: NCT00439959 Terminated - Hepatitis C Clinical Trials

Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults

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

This study represents the first administration of GSK625433 in humans. The study is designed to evaluate initial safety and tolerability in healthy adults as well as anti-viral activity in Hepatitis C(HVC) infected adults. The way the human body processes GSK625433 will also be investigated.

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: NCT00423800 Terminated - Clinical trials for Hepatitis C, Chronic

Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)

Start date: December 2006
Phase: Phase 3
Study type: Interventional

This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48 weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve Hepatitis C Virus (HCV) genotype 1 high viral load (HVL) participants who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at Week 4. HVL will be defined as HCV-RNA of >600,000 IU/mL prior to the initiation of therapy. Participants with genotype 1 baseline HVL prescribed Pegetron® (peginterferon and ribavirin) in the usual manner in accordance with the marketing authorization and who are viral negative at Week 4 will be randomized at Week 8 to receive a total of 24 or 48 weeks of therapy. Participants will be required to have their baseline and Week-12 viral load analyzed by the same local laboratory using the standard of care test used by the site. Qualitative testing at Week 4, 8, 16-20, 24, and 48 may be conducted either by local laboratory or a central laboratory identified by the sponsor using an assay specified by the sponsor. No additional interventions outside of the clinic's standard of care and the conditions of the Canadian product monograph for Pegetron® will be applied to participants.

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.