Active clinical trials for "Hepatitis B, Chronic"

The focus of the study is to identify viral factors and host immune responses that differentiate HBV-related HCC patients from HBV patients who have not progressed to HCC. To that end, the investigators will compare gene expression levels between HCC patients and non-HCC patients categorized into high and low risk profiles. The investigators will perform ANOVA to compare three groups (HCC, high risk, low risk). Multiple comparison corrections will be performed using Benjamini and Hochberg False Discovery Rate (FDR) with a 90% confidence that the discovery lists will contain no more than 5% false positives (FDR<0.05) (PMID: 12584122, 11682119). A p-value <0.05 is considered statistically significant using this multiple comparison correction approach. Post-hoc Student-Newman-Keuls or Tukey tests will be used following ANOVA for comparisons of HCC patients with high risk and low risk. If data are not normally distributed when log-transformed, then Kruskall-Wallis tests will be used. ANCOVA will be used to adjust for the effects of covariates, such as age, gender, and HBV genotype (B or C). Further, the investigators often use an additional 2-fold change criterion for significance because the investigators consider a fold change of this magnitude to be biologically significant. Hierarchical clustering analyses and principal component analyses will be used to visualize how well the genes separate the groups, or to discover new subgroups. For the analysis of SNVs, the exact binomial test will be performed and p-values will be adjusted by the Benjamini-Hochberg correction.

Hepatocellular carcinoma (HCC), listed among lung and breast cancers as the top-ten cancer in 2016 Taiwan, is the second most prevalent cancer, just one place below colon cancer. Due to mass hepatitis B vaccination and the screening and therapeutic plan against hepatitis B and C viruses (HBV and HCV, respectively), the incidence of liver cancer drops significantly, however, still around twenty out of per hundred thousand population die from liver cancer each year. For patients suffering HBV and HCV, the prevention of HCC is a crucial health issue.

The current proposed study aims to bring answers following issues: the antiviral efficacy and safety profiles in Korean Chronic Hepatitis B (CHB) patients who are mostly infected with solely genotype C HBV, a proper duration of Pegasys® therapy post-treatment durability or accumulation of HBeAg seroconversion/HBsAg loss, preventable effect on long-term disease progression to liver cirrhosis and liver cancer. In addition, this study aims to collect more data on the efficacy and safety in a real-life clinical setting of Pegasys® therapy in patients with CHB.

Liver fibrosis is the key step for progression to cirrhosis and liver cancer in patients with chronic hepatitis B (CHB). It is crucial to identify significant liver fibrosis in the treatment of CHB patients. Hence, the investigators aim to construct and validate a new nomogram model for evaluating significant liver fibrosis in CHB patients. The nomogram was based on a retrospective study of 259 CHB patients, who underwent liver biopsy. Through random grouping, 182 cases (70%) were included in the training set and 77 cases (30%) were included in the validation set. Biopsy pathological stage was used as the gold standard to screen the factors included in the model. The receiver operating characteristic (ROC), area under the ROC curve (AUC), calibration curve, and decision curve analysis were used to evaluate the diagnostic effect of this nomogram model. In addition, the investigators will compare the diagnostic efficiency of the new nomogram model with APRI, FIB-4, and GPR.

To investigate the safety and efficacy of tenofovir alafenamide (orally 25 mg per day) treated in inactive chronic hepatitis B virus (HBV)-infected pregnant women with high viral load from the late pregnancy until the delivery date or postpartum 1 month.

Populations from Sub-Saharan Africa represent one of the most dynamic immigration flows in France and are among the most exposed to HIV infection and hepatitis B. The Parcours study aims to understand, among sub-Saharan African migrants, how social and individual factors combine in the course of migration and settlement in France, and influence the risk of infection, access to prevention and care, and the effectiveness of care for both HIV and hepatitis B diseases. The research was conducted in Ile-de-France, where 60% of sub-Saharan African migrants reside. It consists in a cross-sectional observational survey, using a life-event history approach that reproduces the sequence of different life and health events, and contributes to explain the present situation (type of disease management, patient's quality of life) in light of all the elements of the past trajectory (administrative, familial, socio-economic, professionals). A representative survey was conducted between February 2012 and May 2013 in health care facilities in Ile-de-France, among three groups of migrants from Sub-Saharan Africa: a group living with HIV, a group living with chronic hepatitis B and a group who has neither of these diseases. For each group, stratified random sampling was used. The survey was conducted in 24 hospital services providing HIV care, 20 health care facilities providing hepatitis B care, and 30 primary health care facilities. Were eligible all patients attending these health care facilities, born in a Sub-Saharan African country and with Sub-Saharan African citizenship at birth, aged 18 to 59 years, with an HIV diagnosis (HIV group) or chronic hepatitis B diagnosis (hepatitis B group) more than three months prior or not diagnosed with HIV or chronic Hepatitis B (reference group). Among the patients offered participation, 926 HIV-infected patients, 779 patients infected by hepatitis B, and 763 patients without these two diseases participated in the study. For all participants, detailed information on socio-demographic characteristics; migration and life conditions in France; social, sexual and reproductive life history; and screening and care history were collected using a life-event history questionnaire administered face-to-face by a specialized interviewer. Health care professionals documented clinical information from the medical records. Data was collected anonymously.

This study aims at estimating the prevalence of chronic hepatitis B virus (HBV) infection in rural Senegal (area of Niakhar) and at evaluating the associated burden in terms of both health-related and socio-economic consequences.

The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B / hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN). In this protocol, similar reduction/clearance of serum HBsAg and improved response to immunotherapy were observed in addition to clearance of serum HDV RNA. The REP 301 protocol was designed to include a 24 week follow-up period after treatment, however given the strong antiviral response against HBV and HDV infection in these patients, it is now important to extend the follow-up period in these patients to monitor over a longer period after treatment the safety and efficacy combined REP 2139-Ca / peg-IFN treatment in patients in the REP 301 protocol.

The World Health Organization recommends that all high endemic countries for HBV infection based their mother to child transmission prevention strategies on vaccination of all children and administration of immunoglobulins (HBIG) to infants born to infected mothers in the first 24 hours after birth. Lack of access to antenatal screening and to HBIG significantly results in failure of this strategy in many countries. Moreover, despite sero-vaccination, 10 to 15% of infants of mothers that are positive for HBsAg and HBeAg are still infected, as high levels of HBV replication occurring in the third quarter of pregnancy act as a major risk factor. The objective of this study is to assess the effectiveness of an operational strategy to prevent HBV mother-to-child transmission (MTCT) in Cambodia based on the use of rapid tests HBs Ag and HBe Ag to screen HBV infection and a treatment by TDF for patients with a positive HBeAg test with a "test and treat" strategy for those seen for Antenatal Care (ANC) from 24 weeks of amenorrhea. In all cases, vaccination of the newborn will be carried out according to the national protocol in Cambodia i.e. 4 injections at 24 hours, 6, 10 and 14 weeks of age. A phase IV multicenter observational and interventional non randomized prospective study will be conducted in 4 maternity in Cambodia. The primary outcome will be the proportion of active HBV infection in new-born at 6 months of life estimated by HBs Ag positivity. The study will aim to document the acceptability and the operational implementation of the study using rapid tests usable in all health centers and a drug available in all the country thanks to HIV national program. The results will be helpful for Cambodian government in order to implement guidelines and algorithm follow-up for HBV-infected pregnant women.

This observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.