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Hepatitis, Chronic clinical trials

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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: NCT00375895 Terminated - Chronic Hepatitis C Clinical Trials

Switch From Tacrolimus to Cyclosporin in the Treatment of Recurrent Hepatitis C After Liver Transplantation

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

In France, 50% of hepatitis C virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is constant after transplantation and recurrence causes chronic liver disease in 50 to 80% of cases. The aim of this study is to assess the efficacy of cyclosporin on C virological response. Patients included in the Transpeg 1 study and non-responder or with a recurrent disease will be switched from their tacrolimus therapy to cyclosporin, in association with a 1 year peginterferon alfa-2a / ribavirin bitherapy. Efficacy will be assessed by the percentage of patients with a negative qualitative PCR after 19 months of cyclosporin treatment.

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: 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: NCT00277758 Terminated - Hepatitis C Clinical Trials

Safety Study of Low Dose Interleukin 2 (IL-2) Plus PEG-IFN/RBV In Chronic Hepatitis C Virus Genotype I

Start date: March 2004
Phase: Phase 1
Study type: Interventional

This is a treatment study trial, in which we will assess the safety and tolerability of daily dose IL-2, as monotherapy for 12 weeks, followed by IL2 in combination with PEG-IFN and RBV for 48 weeks in the treatment of chronic Hepatitis C.

NCT ID: NCT00274495 Terminated - Fatty Liver Clinical Trials

Assessing the Efficacy and Safety of Rosiglitazone Added to Standard Therapy for Hepatitis C Genotype 1 With Fatty Liver

Start date: January 2006
Phase: Phase 4
Study type: Interventional

To study the effectiveness and safety of adding Rosiglitazone, an insulin sensitizing agent to people with chronic hepatitis C infection genotype 1 with fatty liver disease, who are being treated with standard therapy. Standard therapy consists of weekly pegylated interferon injections and daily ribavirin pills, whose dosage is weight based. This regimen in genotype 1 patients is effective in only 45% of patients at best. In addition, this therapy must be given for 48 weeks to be effective and has alot of side-effects. One risk factor for a poor response is fatty liver. Rosiglitazone has been shown to be effective in the treatment of patients with fatty liver alone. This study hopes to show that the addition of Rosiglitazone to the standard therapy in genotype 1 patients with fatty liver disease will increase effectiveness of the standard therapy of hepatitis C.

NCT ID: NCT00221286 Terminated - HIV Infections Clinical Trials

Efficacy and Safety of PegIFN +/- FTC / TDF to Treat Chronic Hepatitis B in HIV-Coinfected Patients

Start date: September 2004
Phase: Phase 3
Study type: Interventional

The efficacy of pegylated interferons in the treatment of chronic hepatitis B has shown superior results to standard of care in patients only infected with hepatitis B. The efficacy of pegylated interferon for the treatment of chronic hepatitis B in HIV-coinfected patients is not known at present. The purpose of this study is to evaluate the efficacy of pegylated interferon in the treatment of chronic hepatitis B in HIV-infected individuals. Apart from evaluating the efficacy of pegylated interferon therapy in this setting as such, i.e. in patients without present or future need of highly active antiretroviral therapy (HAART) for HIV-infection, there is a second purpose of this study, to investigate whether combination treatment of HBV-infection may be superior to pegylated interferon therapy alone. Therefore patients without need of HAART are offered pegylated interferon alfa-2a over 48 weeks. Patients who require HAART are offered emtricitabine / tenofovir DF containing HAART over 72 weeks PLUS pegylated interferon alfa-2a over 48 weeks vs. emtricitabine / tenofovir DF containing HAART over 72 weeks WITHOUT pegylated interferon-alfa-2a.

NCT ID: NCT00209898 Terminated - Chronic Hepatitis C Clinical Trials

Hepatitis C Treatment of Inmates

PEGPRI
Start date: August 2003
Phase: Phase 4
Study type: Interventional

Hepatitis C infection is a prevalent chronic disease. It is particularly prevalent among intravenous drug abusers. Bergen fengsel is a regional prison housing 250 inmates, of which as many as 70 are recorded HCV RNA PCR positive annuallly. In this study inmate males and females will be randomized to standard screening and initiation procedure, or to a rapid initiation procedure in the hospital's infectious diseases outpatient clinic. The study aims at studying if rapid inclusion will increase the possibility to conclude treatment while the prisoner still is incarcerated, thus improve the chances of reaching a sustained virologic response, compared to standard inclusion, where prisoners, as other out patients will wait for inclusion for several months.

NCT ID: NCT00209755 Terminated - Chronic Hepatitis C Clinical Trials

Plasma Ribavirin Assay During Combination Therapy for Chronic Hepatitis C

Start date: October 2003
Phase: N/A
Study type: Interventional

Investigation of the usefullness of therapeutical drug monitoring of ribavirin for dose adaptation during combination therapy of chronic hepatitis C patients. The correlation between ribavirin plasma concentration levels at week 4 (steady state) and early virological response (HCV-RNA decay from baseline to week 12) is to be tested in 40 patients approximately.

NCT ID: NCT00120796 Terminated - Hepatitis B Clinical Trials

Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection (ANRS 12100 HEPADAK-2)

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

Chronic hepatitis B infection is a major public health issue in Senegal. The study will compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine (12 intra-muscular injections over a 6-month period) to a treatment with Lamivudine alone on the control of viral replication in patients with a replicative hepatitis B virus (HBV) infection and an increase in hepatic enzymes.