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Hepatitis clinical trials

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NCT ID: NCT00671671 Completed - Hepatitis C Virus Clinical Trials

Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.

Start date: April 2008
Phase: Phase 1
Study type: Interventional

Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics, safety and efficacy in subjects with no or inadequate response to prior treatment.

NCT ID: NCT00670839 Completed - HIV Infection Clinical Trials

Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding to Primary Immunization (B-BOOST)

B-BOOST
Start date: May 2008
Phase: Phase 3
Study type: Interventional

HIV infected patients exposed to Hepatitis B virus are more susceptible to develop a chronic and severe liver disease, with a major risk of cirrhosis and liver cancer. However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected patients, compared to non HIV-infected individuals, and, in case of response, its durability has to be carefully followed up. This study compares the efficacy of two strategies of revaccination in HIV-infected patients who didn't respond to previous hepatitis B vaccination. Failure is defined by two conditions: non response to the primary immunization (2 to 4 single-dose injections received before the screening visit) and failure to a single 20 µg boost before being included in the study.

NCT ID: NCT00668369 Completed - Clinical trials for Liver Transplantation

Effect of Immunosuppression Drug Weaning on Hepatitis C Virus (HCV)-Induced Liver Damage After Liver Transplantation

Start date: April 2008
Phase: Phase 2
Study type: Interventional

Viral infections can profoundly influence alloimmune responses and hamper allograft tolerance induction. Persistent hepatitis C virus (HCV) infection occurs in 50% of liver and 20% of kidney transplant recipients, but the impact of HCV on the acquisition of allograft tolerance has not been elucidated. Liver transplantation constitutes a unique clinical model to address this question, given that up to 20% of liver recipients can completely discontinue immunosuppressive drugs and attain operational tolerance. The goal of our study is to determine the influence of HCV-driven immune responses on the acquisition of operational tolerance in liver transplant recipients following drug weaning, and to assess whether immunosuppression withdrawal ameliorates HCV-induced liver damage. This is a prospective trial in which immunosuppressive drug weaning will be offered to HCV-positive liver recipients (selected on the basis of a high likelihood of tolerance) as a strategy to improve HCV-mediated liver disease.

NCT ID: NCT00665353 Completed - Clinical trials for HIV-1 and Hepatitis C Co-Infection

Pioglitazone Before Peginterferon and Ribavirin for Hepatitis C Infection in HIV/HCV-Coinfected Patients With Insulin Resistance

Start date: March 2009
Phase: Phase 2
Study type: Interventional

Insulin resistance is common in people coinfected with HIV and Hepatitis C virus (HCV) and is associated with poor responses to treatment for HCV. Pioglitazone is an FDA-approved medication for the treatment of type 2 diabetes. It works by increasing the body's sensitivity to insulin. The purpose of this study is to determine whether treatment with pioglitazone prior to HCV treatment with peginterferon and ribavirin is safe and effective in improving the treatment outcome in insulin-resistant, HIV/HCV-coinfected people for whom previous treatment with peginterferon and ribavirin was unsuccessful.

NCT ID: NCT00664625 Completed - Chronic Hepatitis C Clinical Trials

A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects

Start date: May 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-791325 in subjects with chronic hepatitis C infection

NCT ID: NCT00663208 Completed - Chronic Hepatitis C Clinical Trials

A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects

Start date: May 2008
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection

NCT ID: NCT00662545 Completed - HIV Infections Clinical Trials

Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection

Start date: April 2008
Phase: Phase 4
Study type: Interventional

This study will evaluate HIV-HBV infected individuals who have evidence of HBV replication in the blood after taking 48 weeks of more of the HBV active medication tenofovir in combination with emtricitabine or lamivudine. Eligible participants will be randomized to receive 24 weeks of entecavir (ETV) 1 mg versus continued standard of care antiretroviral therapy. After 24 weeks, individuals on entecavir or who remain HBV viremic on standard of care will receive ETV o for an additional 24 weeks. The hypothesis is that intensification with entecavir will reduce HBV DNA at 24 weeks more than continued antiretroviral therapy without entecavir.

NCT ID: NCT00661076 Completed - Clinical trials for Hepatitis B, Chronic

ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B

Start date: August 2008
Phase: Phase 3
Study type: Interventional

This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180 micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

NCT ID: NCT00659256 Completed - Atherosclerosis Clinical Trials

Hepatitis C Treatment and Atherosclerosis

Start date: April 8, 2008
Phase:
Study type: Observational

This study will examine the effects of treatment for hepatitis C on atherosclerosis, or hardening of the arteries. Hepatitis C is a disease of the liver caused by a virus that can cause permanent damage to that organ. Treatment can clear the virus in at least half of patients and reduce the risk of serious complications of the disease. Atherosclerosis is an accumulation of cholesterol and fat in the arteries that can narrow blood vessels, leading to chest pain, heart attack or stroke. Because the liver controls cholesterol and fat levels in the blood, hepatitis C infection may be a risk factor for atherosclerosis by increasing cholesterol and fat in blood vessels. Treatment of the hepatitis C may reduce the risk of atherosclerosis and its consequences. This study will determine what effect hepatitis C treatment has on the rate of atherosclerosis and narrowing of blood vessels and on the risk of heart attack or stroke. Patients 30 years of age and older with current or past infection with hepatitis C may be eligible for this study. Participants undergo the following tests and procedures: - Questionnaires regarding risk factors for heart disease and stroke - Measurements of blood pressure, heart rate, weight, height, waist and hips - Blood tests - CT scans and ultrasound tests to measure the degree of blood vessel hardening and narrowing in the heart and neck region

NCT ID: NCT00657657 Completed - Hepatitis B Clinical Trials

Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine

Start date: April 2008
Phase: Phase 4
Study type: Interventional

In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine at 0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for immunological memory to hepatitis B vaccine via assessment of the response to a vaccine challenge dose.