A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
Summary
The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine will be well-tolerated and induce HBV-specific virological and immunological responses in chronic hepatitis B (CHB) patients.
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Hepatitis B, Chronic
Intervention
DV-601, Entecavir
Location
Collegium Medicum Uniwersytet im. Mikołaja Kopernika
Bydgoszcz
Poland
85-030
Status
Recruiting
Source
Dynavax Technologies Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01023230
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Hepatitis C, Chronic
INFLAMMATION of the LIVER in humans that is caused by HEPATITIS C VIRUS lasting six months or more. Chronic hepatitis C can lead to LIVER CIRRHOSIS.
Hepatitis, Chronic
INFLAMMATION of the LIVER with ongoing hepatocellular injury for 6 months or more, characterized by NECROSIS of HEPATOCYTES and inflammatory cell (LEUKOCYTES) infiltration. Chronic hepatitis can be caused by viruses, medications, autoimmune diseases, and other unknown factors.
Hepatitis D, Chronic
INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS in conjunction with HEPATITIS B VIRUS and lasting six months or more.
Hepatitis B E Antigens
A closely related group of antigens found in the plasma only during the infective phase of hepatitis B or in virulent chronic hepatitis B, probably indicating active virus replication; there are three subtypes which may exist in a complex with immunoglobulins G.
Hepatitis Delta Virus
A defective virus, containing particles of RNA nucleoprotein in virion-like form, present in patients with acute hepatitis B and chronic hepatitis. It requires the presence of a hepadnavirus for full replication. This is the lone species in the genus Deltavirus.
Clinical Trials
An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection
To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hep...
The purpose of this clinical research study is to assess the safety and effectiveness of switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.
Entecavir for Subjects With Chronic Hepatitis B Infection: An Early Access Program
The purpose of this clinical research study is to provide entecavir to subjects with chronic Hepatitis B infection who have failed or who have demonstrated intolerance of marketed therapie...
The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus in subjects who receive an orthotopic liver transplant...
The purpose of this study is to show that the combination of entecavir and tenofovir will be safe, well tolerated and effective in chronic Hepatitis B patients who have failed previous tre...
PubMed Articles
The oral deoxyguanosine nucleoside analogue entecavir (Baraclude®) has potent activity against hepatitis B virus (HBV) and a high genetic barrier to resistance. This article reviews the clinical effi...
BACKGROUND: The outcomes of sequential therapy with lamivudine followed by interferon have been unsatisfactory in Japanese patients with hepatitis B envelope antigen (HBeAg)-positive chronic hepatitis...
Background/Aims: Sequential antiviral therapy for chronic hepatitis B may lead to the selection of multidrug-resistant mutation. This study was carried out to assess the efficacy of entecavir in patie...
Entecavir rescue therapy is frequently used in patients with lamivudine-resistant hepatitis B virus (HBV) strains. The aim of this study was to investigate evolutionary patterns of HBV quasispecies du...
We report a case of an immunocompromised patient affected by chronic hepatitis B virus (HBV) with high basal HBV viremia (>8 log(10) IU/ml) who failed an entecavir regimen, despite the absence of pri...
