View clinical trials related to Hepatitis B.
Filter by:The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We spoke first from HBsAg" healthy carrier ", then from " asymptomatic carrier ", last from HBsAg" inactive carrier ". This definition continue to be not totally consensual. A very low viral load (< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40 UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg quantification for the prognosis of such events or, in contrary HBs seroconversion; will evaluate the influence of B genotype on HBsAg level; will evaluate the influence of comorbidities on unexpected arrival of such events.
REP 2139-Ca is nucleic acid polymer. Nucleic acid polymers have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV infected ducks) and in human patients and to act synergistically with immunotherapeutic agents such as pegylated interferon-alpha 2a or thymosin alpha-1 to restore host immunological control of HBV infection. HBsAg is an essential component of the hepatitis D virus (HDV), therefore the direct action of REP 2139-Ca in removing serum HBsAg and its synergistic effect with pegylated interferon-alpha 2a is expected to have a significant antiviral effect against HDV infection. This study will examine the safety and efficacy of REP 2139-Ca therapy when used in combination with pegylated interferon alpha-2a in patients with HBV / HDV co-infection. The primary hypothesis to be tested is that this combined dosing regimen is safe and well tolerated in patients with HBV / HDV co-infection which will be assessed by examining the number of patients with adverse events (including reported symptoms and laboratory abnormalities). The secondary hypothesis to be tested is that this combined dosing regimen will have an antiviral effect against HBV / HDV co-infection in these patients which will be assessed by examining the following outcomes: 1. The number of patients with reductions in serum HBsAg. 2. The number of patients with reductions in serum HDAg and HDV RNA 3. The number of patients that experience a sustained antiviral response after treatment is stopped (reductions in serum HBV DNA and HDV RNA). The secondary hypothesis to be tested is that this combination approach can have an effective
Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver disease that predisposes patients to the development of hepatocellular carcinoma (HCC). Active hepatitis B virus (HBV) replication is the key driver of liver injury and disease progression. Majority of Chinese patients are infected with genotype B and C HBV, which is different from Caucasian counterparts. This prospective multi-center cohort open-label study is designed to investigate the long-term effect of TDF on prevention of HCC and disease progression as well as to evaluate the efficacy and safety of long-term TDF in Chinese CHB subjects with advanced liver diseases. The study will enrol 240 subjects.
The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore, the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.
The purpose of this study is to evaluate the efficacy of Oxymatrine plus Lamivudine Combination Therapy and whether it could lower the incidence of Lamivudine long-term resistance compared to Lamivudine Monotherapy.
This open--label, multicenter, national observational study will investigate the effectiveness of standard of care treatment with peginterferon alfa-2a in participants with chronic hepatitis B (CHB). Participants who have never received any hepatitis B virus (HBV) treatment and participants previously treated with nucleos(t)ide analogs (NAs) are qualified for enrollment. The observation period is 48 weeks (peginterferon alfa--2a standard of care treatment) and for up to 24 weeks thereafter (72 weeks in total).
This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues (NAs). The study will enrol 200 CHB subjects following failure of multiple NAs. Subjects will be assessed for eligibility at a screening visit, with eligible subjects returning for a baseline assessment after approximately 4 weeks (Screening phase). In the treatment phase all enrolled subjects will receive open label TDF at a dose of 300 milligrams (mg) orally once daily. All the eligible study subjects will undergo safety and efficacy assessments every 12 weeks for a total of 14 visits. Tenofovir disoproxil fumarate, the oral pro-drug of tenofovir (TFV), is a nucleotide analogue that inhibits viral polymerases by direct binding and after incorporation into deoxyribonucleic acid (DNA), by termination of the DNA) chain. TDF is a highly potent treatment in treatment-naïve and lamivudine (LAM) resistant CHB patients. The purpose of our study is to evaluate the efficacy of TDF treatment in Chinese CHB patients following failure of multiple NAs. In addition, the study will also explore the relationship of baseline factors and early HBV DNA suppression to long-term virological response. The efficacy of TDF in multi-drug resistant patients will be analysed separately. The data generated by this study could then be used to optimize the clinical application of TDF and provide new evidence for management of the HBV infections following failure of multiple NAs. The result of this study will help Chinese physicians better manage the CHB patients following failure of multiple NAs.
A proof of concept (POC) study will be conducted in 44 volunteers that have been fully vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and immunogenicity of intradermal vaccination with hepatitis B surface vaccine antigen using a newly developed intradermal injection device VAX-ID, compared to intramuscular and intradermal (Mantoux technique) injection.
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.
This study looks at protection in 10-11 and 15-16 year olds, immunized as infants with Hepatitis B (HB) vaccine to see if they still have residual protection against Hepatitis B disease. Adolescents will be invited to have a blood test and those without a minimal level of protection (antibody titer) will be offered a "test" vaccination to see if they still have capacity to recall an immune response. About one month later they will get another blood test to see if a booster response occurred. A few participants will have lost protection (no booster response) and will be offered a second HB vaccination to restore protection. Results of this study could influence the way in which children in British Columbia (BC) are immunized against HB disease.