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Hepatitis C clinical trials

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NCT ID: NCT00422838 Completed - Hepatitis C Clinical Trials

Study Investigating Immunological Effects of Treatment for Chronic Hepatitis C Patients.

CIRES
Start date: January 2007
Phase: N/A
Study type: Observational

Aim To evaluate the effects of peginterferon and ribavirin therapy on the immune response in chronic HCV genotype 1,2 or 3 patients before, during and after treatment. Background Treatment of chronic hepatitis C (HCV) has shown a remarkable success. However, genotype 1 patients have reduced response rates. A better understanding and improvement of these results can now be considered the greatest challenge. In chronically infected patients, HCV-specific immune responses are generally weak, narrowly focused, and often dysfunctional. The presence of HCV-specific cells suppressing the immune response (regulatory T-lymphocytes=Treg) are able to suppress the immune response. These Treg are possibly responsible for the impaired immune response. Previous studies have indicated increased Treg frequency and activity of immune regulating mechanisms, locally in the liver, as a result of HCV re-infection. Hence, these Data highlight the importance of monitoring intrahepatic immune responses in addition to peripheral immune responses. Using the minimally-invasive technique of fine-needle aspiration biopsy (FNAB), it is now possible to obtain safe and frequent liver samples to monitor local antiviral immune responses in chronic HCV patients during antiviral therapy. Rationale and hypothesis of the study Our previous studies and current literature support the concept that Treg may contribute to HCV persistence by suppressing HCV-spec immune responses. The current study is designed to examine if peginterferon and ribavirin therapy affects the activity of Treg and DC, and if this results in enhanced HCV-specific immune responses. Design Single centre, translational and observational open label study with one arm of 20 genotype 1 patients and one arm of 7 genotype 2/3 patients.

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: NCT00420784 Completed - Hepatitis C Clinical Trials

A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)

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

The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.

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.

NCT ID: NCT00418054 Completed - Chronic Hepatitis C Clinical Trials

Study of Nitazoxanide Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Hepatitis C

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

The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon alfa-2b combination therapy compared to peginterferon monotherapy in patients that are treatment naive or pre-treated for 24 weeks with nitazoxanide monotherapy in the treatment of chronic hepatitis C.

NCT ID: NCT00412334 Completed - Clinical trials for Hepatitis C, Chronic

SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.

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

This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00411385 Completed - Chronic Hepatitis C Clinical Trials

Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3

Start date: February 2007
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.

NCT ID: NCT00408304 Recruiting - Chronic Hepatitis C Clinical Trials

Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.

Start date: December 2006
Phase: Phase 2
Study type: Interventional

The purpose of the study is to check whether development of depression as a side effect of interferon alpha treatment in chronic carriers of hepatitis C can be prevented by omega-3 fatty acids.

NCT ID: NCT00407732 Completed - Hepatitis C Clinical Trials

Overcoming Psychiatric Barriers to the Treatment of Hepatitis C

Start date: January 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate candidates for interferon therapy.

NCT ID: NCT00403533 Completed - Hepatitis C Clinical Trials

Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus

Start date: February 2006
Phase: Phase 2
Study type: Interventional

We hypothesize that atorvastatin will decrease HCV viral load in patients taking the medication. Cholesterol is needed for HCV virion production. Cell culture studies have shown that atorvastatin (an HMG-CoA reductase inhibitor) decreases HCV viral replication. As atorvastatin has been proven to decrease heart attack and stroke in patients with high cholesterol, this medication is indicated for the treatment of elevated cholesterol in at risk individuals. Therefore we propose to study the effect atorvastatin has on the viral load of patients initiated on atorvastatin therapy for their elevated cholesterol.