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Hepatitis clinical trials

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NCT ID: NCT00473668 Completed - Hepatitis B Clinical Trials

Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib

Start date: June 1, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00467545 Completed - Chronic Hepatitis B Clinical Trials

An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

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

This study is to evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial. Patients treated with telbivudine during core phase will continue telbivudine and patients treated with entecavir during core phase will be switched to telbivudine if the patient is willing to enroll this study.

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: NCT00466219 Completed - Hepatitis C Clinical Trials

Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant

Start date: May 2002
Phase: Phase 3
Study type: Interventional

The aim of the study is to assess whether patients with recurrent hepatitis C after liver transplantation will benefit from a treatment with ribavirin/PEG-IFN-alpha combined treatment for 48 weeks.

NCT ID: NCT00456625 Completed - Hepatitis B Clinical Trials

Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.

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

The current study will evaluate immunological memory to hepatitis B antigen in subjects who received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in the primary study and who have anti-HBs antibody concentrations < pre-defined cut-off values at the previous long-term time point. All participating subjects will receive a challenge dose of hepatitis B vaccine. Subjects will be aged approximately 20-21 years at the time of this study. No new subjects will be recruited in this long-term follow-up study. Blood sampling will be done one month after the administration of the challenge dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00446940 Completed - Hepatitis C Clinical Trials

Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C

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

Different Doses of rosuvastatin and atorvastatin will be used to see if HCV viral load changes and liver tests change.

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: NCT00445315 Completed - Hepatitis C Clinical Trials

A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients

Start date: January 2007
Phase: Phase 1
Study type: Interventional

Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in HCV positive patient volunteers

NCT ID: NCT00444002 Completed - Hepatitis C Clinical Trials

Oxidative Stress and Fatty Acids in Hepatitis C

Start date: July 2005
Phase: N/A
Study type: Observational

Hepatitis C virus infection (HCV) is a major health concern in Canada and worldwide. Chronic HCV can cause progressive liver damage leading to inflammation, scarring and, in some cases, cirrhosis or liver cancer. It has been shown that fat accumulation in the liver can accelerate the disease progression and is therefore a risk factor in HCV patients. However, the exact mechanism(s) by which fat accumulation in the liver is involved in disease progression are not clear yet. It is possible that the presence of fat provides a liver susceptible to a second injurious process which leads to scarring. Candidates for this second "hit" may include insulin resistance, leading to accumulation of fat within the liver cells and secondly oxidation of these lipids. In turn, lipid peroxidation can lead to production of reactive oxygen species (unstable molecules that can damage cells) and cytokines (signal molecules that promote inflammation) resulting in more oxidative stress and liver damage. Aim of the study is to find out, whether patients with HCV and fatty liver have increased oxidative stress and inflammation than patients with HCV without fatty liver, and whether this is associated with a different nutritional status.