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Hepatitis C, Chronic clinical trials

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NCT ID: NCT00310336 Completed - Hepatitis C Clinical Trials

Chronic Hepatitis C Non-Responder Study With AdoMet and Betaine

Start date: August 2006
Phase: Phase 2/Phase 3
Study type: Interventional

50-60% of patients with chronic hepatitis C are not cured by treatment with pegylated IFNα plus ribavirin. Retreatment of non-responders of previous (pegylated) IFNα plus ribavirin therapies with pegylated IFNα plus ribavirin results in a sustained response in less than 10% of the patients. Extensive analysis of IFNα signaling in cells expressing HCV proteins, in transgenic mice expressing HCV proteins, and in liver biopsies from patients with chronic hepatitis C point to STAT1 methylation as an important posttranslational modification targeted by HCV to inhibit IFNα signaling. STAT1 methylation can be increased and IFNα can be improved by adding AdoMet and betaine. The study is designed to test the hypothesis that a combination treatment with pegylated IFNα2b, ribavirin, AdoMet and betaine is superior to the current standard combination therapy with pegylated IFNα plus ribavirin.

NCT ID: NCT00305383 Terminated - Clinical trials for Hepatitis C, Chronic

Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C

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

The purpose of this study is to examine the rapid virologic response (RVR) at combination therapy (CT) Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.

NCT ID: NCT00304551 Completed - Liver Cirrhosis Clinical Trials

A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)

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

This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC. Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.

NCT ID: NCT00302081 Completed - Clinical trials for Hepatitis C, Chronic

Three Regimens of PegIntron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548)

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

This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.5/R (24 weeks)], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.0/R (24 weeks)], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks [Arm PEG2b 1.5/R (16 weeks)] .

NCT ID: NCT00300807 Active, not recruiting - Hepatitis C Clinical Trials

Study of XTL6865 in Patients With Chronic Hepatitis C Virus Infection

Start date: October 2005
Phase: Phase 1
Study type: Interventional

1. Evaluate the safety, tolerability, and virologic activity of escalating single (and multiple) doses of XTL6865, a mixture (1:1) of two human monoclonal antibodies (HCV-AbXTL68 and HCV-AbXTL65), in patients with chronic hepatitis C virus infection. 2. Assess the pharmacokinetics of XTL6865 in the presence and absence of viral infection.

NCT ID: NCT00299936 Completed - Chronic Hepatitis C Clinical Trials

Comparison of PEG-Intron and Two Different Doses of Ribavirin for the Treatment of Chronic Hepatitis C In Treatment Naïve Subjects

Start date: n/a
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare PEG-interferon alfa-2b and two different doses of rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects

NCT ID: NCT00299923 Active, not recruiting - Clinical trials for Hepatitis C, Chronic

Study for Patients With Chronic HCV (GT 1 or 3) Who Relapsed to Previous (Peg)Interferon/ Ribavirin Combination Therapy

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

The aim of this study is, to compare the relapse rate in chronic HCV patients with genotype 1 or 3 under the combination of standard dose Peg-Interferon alfa-2a (PEG-IFN alfa-2a), Ribavirin (RBV) and Amantadine (AMA) given for 72 weeks (group A), versus the same combination, given for 48 weeks (group B) in patients who relapsed to previous combination therapy to conventional or pegylated (PEG) Interferon alfa and Ribavirin. Relapse ist defined as percentage of patients with non-detectable HCV-RNA at end of therapy (week 48 GT1/ week 24 GT 3) who become HCV-RNA positive during a follow-up period of 24 weeks.

NCT ID: NCT00298714 Completed - Chronic Hepatitis C Clinical Trials

Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

Start date: March 2003
Phase: Phase 4
Study type: Interventional

There is evidence on the beneficial effects of the administration of angiotensin II type 1 (AT1) receptors antagonists on liver fibrosis in hepatic stellate cells, experimental models of liver fibrosis in rodents and limited information in chronic hepatitis C with mild fibrosis. The purpose of this study is to investigate the effect of long-term administration of oral Losartan, an AT1 receptor antagonist, on liver fibrogenesis in patients with chronic hepatitis C and fibrosis F2-F3 (METAVIR score).

NCT ID: NCT00296972 Terminated - HIV Infections Clinical Trials

Tolerability of Peginterferon Plus Ribavirin for Chronic Hepatitis C and HIV for Patients Receiving Antiretroviral Medication vs Not Receiving Antiretroviral Medication

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

The main purpose of this study is to compare the safety, effectiveness and tolerability of using Pegasys with Copegus in people who have both the hepatitis C virus (HCV) genotype 1 and HIV who continue taking HAART (highly active antiretroviral therapy) to those who discontinue taking HAART. Canadian guidelines recommend that both HIV and HCV should not be treated at the same time as the medications needed to treat these two diseases may interact and that which disease to treat first is dependent on the CD4 count. In this study, the CD4 count must be over 350 cells and one must be stable on HAART before starting the study medication Pegasys in combination with Copegus.

NCT ID: NCT00294489 Recruiting - Clinical trials for Chronic Hepatitis C Virus Infection

Methacetin Breath Test in HCV Patients With Normal and Near-Normal ALT

Start date: February 2006
Phase: Phase 3
Study type: Observational

A relatively large proportion of patients with chronic HCV infection have normal or mildly elevated ALT. Many of these patients are not being treated, and are not being sent for a liver biopsy. The present study will determine the ability of Methcetin BreathID Test(MBIT) to detect those patients who will be candidates for anti-viral treatment, as an alternative measure for liver biopsy in decision-making prior to treatment in clinical hepatology.