Hepatitis B

The proposed study aims to evaluate, investigate, and follow-up patients suffering from acute and chronic liver disease. The study will focus on understanding diseases affecting the liver. Patients participating in the study will first undergo a routine check-up as an outpatient. They will be asked to provide blood and urine samples for laboratory testing and will undergo an ultrasound of the liver. Ultrasound examinations use sound waves to determine the size and texture of the liver. After the initial visit subjects will be requested to follow-up once a year at the outpatient department for a similar check-up. Additional tests may be requested throughout the study to provide information for other research studies and individual consent will be requested. These tests may include liver biopsies, skin biopsies, and / or specialized blood, plasma, and lymphocyte examinations. Subjects that qualify for medications presently being studied may be offered the opportunity to benefit from experimental therapy.

The HEAL-S study is a non-interventional study with retrospective data analysis. It consists of two parts. First a retrospective analysis based on nucleic acid testing (NAT) results will be performed. Two cohorts (HCV) and (HBV) will be established. Patients falling into one (or both) of the two cohorts will be invited to a prospective linkage-to-care study. In this part, patients are invited to the clinic, where the possibility of hepatitis treatment will be discussed.

The " CirB-RNA " cohort aims to create a biological collection associated with clinical and biological data from patients with hepatitis B infection. This project is part of a much larger program that aims to characterize and quantify circulating viral RNAs as a possible new biomarker of hepatitis B functional cure.

The REACH-B study establishes an observational cohort study of people living with chronic hepatitis B from a national network, including a diverse range of services, to characterise and monitor hepatitis B linkage to care and treatment requirements amongst this population.

To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.

Observational cohort of adults with acute and chronic hepatitis B infection in Zambia, with and without HIV coinfection. Participants join the study at the time of diagnosis and before or at the time when they are starting antiviral treatments and then they are followed up over multiple years to assess changes to their liver and evolution of HBV (and HIV if applicable) infection. All treatments for HBV and HIV are standard per local Ministry of Health guidelines.

1. Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis. 2. Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat. 3. Explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.

The aim of the study is to screen for hepatitis B, hepatitis C and AIDS viruses using a Dried Blood Spot in drug users

This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB mAb19, which targets the S-protein in individuals with chronic hepatitis B (CHB) on nucleos(t)ide analog therapy (NRTI).

Aim: The main goal of this observational study is to determine the prevalence of Human Papilloma Virus(HPV) infection, and Hepatitis B (Hep B) immunity amongst women of childbearing age 13 to 45 years) attending clinics at Mtshabezi Mission and Matobo clinic respectively; and assess behavioral risk factors of high school students at these catchment areas that can put them at risk for developing cancer of the cervix and liver. Question: Can screening for cancer, and vaccination against Hep B and HPV, and cognitive behavior intervention help in preventing related cancers amongst these groups of participants.

Study Objective: To compare the efficacy and prognosis of systemic cancer therapy between TAF monotherapy and ETV plus TAF combination therapy in patients with unresectable, advanced hepatitis-B-related hepatocellular carcinoma (HBV-HCC). Study Design: Prospective, interventional cohort study. Participants: Patients with histologically or radiologically confirmed unresectable, advanced HBV-HCC who are scheduled to receive immune-based systemic therapy at The Third Affiliated Hospital of Sun Yat-sen University. Detailed inclusion/exclusion criteria are provided below. Intervention: Enrolled participants will be assigned to receive either TAF monotherapy or ETV combined with TAF for HBV suppression. Primary Outcome: Overall survival (OS) at 24 months after initiation of systemic therapy, compared between the two HBV-treatment strategies. Secondary Outcomes: Decline in HBV DNA and HBsAg levels at 1, 3, 12 and 24 months. Sample Size: 120 HCC patients (60 per arm). Statistical Analysis: All analyses will be performed with SPSS. Continuous variables will be tested for normality (Shapiro-Wilk). Normally distributed data are presented as mean ± SD; non-normally distributed data as median (IQR). Twenty-four-month OS will be estimated by Kaplan-Meier curves and compared with a Cox proportional-hazards model adjusted for age, BCLC stage, AFP level, and ICI regimen. PFS will be compared using the log-rank test; ORR and HBV DNA undetectable rate will be compared with χ² tests. Inverse-probability-of-treatment weighting (IPTW) will address selection bias, and multiple imputation will handle missing data.

The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.

The goal of this clinical trial is to learn if HEPLISAV-B, a vaccine that is approved to prevent hepatitis B infection in people that are not already infected, is safe in people already chronically infected with hepatitis B. The main quiestions it aims to answer are: 1. Is HEPLISAV-B safe in people with chronic hepatitis B? 2. What side effects, if any, could HEPLISAV-B cause in people with chronic hepatitis B? 3. How does HEPLISAV-B affect the cells that fight chronic hepatitis B? Participants will: * Receive HEPLISAV-B as an injection in the muscle, one injection every 4 weeks, for a total of 2 injections. * Visit the clinic a total of 5 times, and have 3 phone follow ups over 14 months. * Be asked if they are having any side effects from HEPLISAV-B. * Have blood samples collected.

Examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis, and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation.

The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.

SPHERES is a health service research trial in the Indonesian primary care system designed to improve health system performance using a structured data-driven action model. The intervention empowers district health leaders to make data-informed decisions that will enhance outcomes across maternal, child, infectious, and non-communicable disease programs.

The World Health Organization (WHO) aims to eliminate viral hepatitis as a public health threat by 2030, with major reductions in hepatitis B and C incidence and mortality. However, hepatitis C virus (HCV) transmission has increased among gay, bisexual, and other men who have sex with men (GBMSM), especially those living with HIV. Practices such as chemsex, particularly involving injection drug use, have contributed to this rise. Hepatitis B virus (HBV) also remains a public health challenge due to the potential for chronic infection and severe liver damage. Hepatitis D virus (HDV), which requires HBV co-infection, further complicates clinical management. This study aims to design, implement, and evaluate an online self-sampling testing strategy to enhance pan-viral testing (HBV, HCV, HDV, HIV) and improve linkage to care among GBMSM and transgender women (TW) in Spain. The intervention will involve self-collected dried blood spot (DBS) samples for testing HBV surface antigen (HBsAg), HIV antibodies, and HCV RNA. Individuals testing positive for HBsAg will undergo further testing for HBV DNA and HDV infection. Those lacking protective levels of HBV antibodies will be referred for vaccination or revaccination. The study will also assess the number of HIV-positive individuals who acquired the infection while waiting for access to PrEP, identifying missed prevention opportunities. This non-randomized, single-arm, prospective national study will recruit adult GBMSM and TW through PrEP services, dating apps, NGOs, social media, and community outreach. Participants will complete an online risk assessment (using the HCV-MOSAIC algorithm) and receive self-sampling kits with instructions, lancets, Whatman cards, and prepaid envelopes. Results will be provided online, and those testing positive will be linked to confirmatory diagnosis and care. Outcomes include estimates of HIV, HBV, HCV, and HDV prevalence; effectiveness of linkage to care; acceptability and usability of the intervention; and validation of DBS for HBsAg detection. This study will provide critical evidence on the effectiveness of online self-sampling strategies for viral hepatitis and HIV among GBMSM and TW, supporting Spain's public health goals for prevention, early diagnosis, and linkage to care.

Chronic hepatitis B can develop into cirrhosis and liver cancer, which seriously endangers the life and health of people. In China, HBV is mainly transmitted from mother to child, showing the phenomenon of family clusters. Similarly, cirrhosis and hepatocellular carcinoma occur in familial clusters. Familial clusters of HBV infection with unfavorable prognoses refers to HBV-infected patients from two consecutive generations of blood relatives, with at least one family member diagnosed with hepatitis B-related cirrhosis or hepatocellular carcinoma (HCC). Previous family investigations have shown that the risk and harm of HBV-related cirrhosis and hepatocellular carcinoma are significantly higher in families with familial clusters of HBV infection with unfavorable prognoses than in the general population. Currently, antiviral drugs used for CHB mainly include nucleoside analogues (NAs) and interferon-alpha (mainly pegylated interferon-alpha, Peg IFN). NAs mainly inhibits viral replication by blocking the reverse transcription process, but it cannot effectively inhibit the expression of viral proteins such as HBsAg, and rarely achieves clinical cure. Multiple clinical studies have shown that the use of NAs reduces the incidence of cirrhosis decompensation, HCC, and death in patients with CHB compared to untreated or placebo-treated patients. Despite long-term treatment with first-line NAs drugs, CHB patients continue to be at risk of developing hepatocellular carcinoma. Peg IFN α-2b injection is the first-line drug of choice for antiviral treatment of chronic hepatitis B, and its main mechanism of action includes anti-HBV, anti-fibrosis, anti-tumor and regulation of immune response. In 2024, a randomized controlled multicenter study showed that Peg IFN α-2b combined with NAs therapy could effectively prevent hepatocellular carcinoma in CHB patients. There is sufficient evidence in clinical practice that long-term antiviral therapy, whether NAs or Peg IFN α-2b, reduces the risk of cirrhosis, hepatocellular carcinoma, and death in patients with CHB. In conclusion, early antiviral therapy can reduce the risk of developing hepatitis B cirrhosis and hepatocellular carcinoma in CHB patients with familial clusters of HBV infection with unfavorable prognoses. The goal of this observational study is to explore the evaluation of pegylated interferon α-2b combined with first-line NAs on the long-term outcome of CHB antiviral therapy with cirrhosis and HCC progression as the main observation targets, compared with only use of NAs in the context of familial clusters of HBV infection with unfavorable prognoses. It is intended to provide high-quality evidence-based medical evidence for the treatment and follow-up of CHB, explore optimal clinical decision-making, and provide global clinical data for the improvement and evaluation of this difficult-to-treat population. The main question it aims to answer is: Can Peg IFN-α-2B combined with NAs therapy improve the long-term outcomes of this particular population of familial clusters of HBV infection with unfavorable prognoses compared to first-line NAs monotherapy? Patients with familial clusters of HBV infection with unfavorable prognoses using Peg IFN-α-2B combined with NAs therapy and NAs monotherapy will be collected laboratory and medical examination data at specified follow-up points, and recorded adverse events and drug combinations in detail for 7 years.

The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants

The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients

The main objective of this study is to compare the mother-to-infant transmission rates of hepatitis B between pregnant women receiving treatment with tenofovir alafenamide and those receiving treatment with tenofovir disoproxil fumarate, after administering the hepatitis B vaccine and hepatitis B immunoglobulin to their infants at birth. Investigators define the mother-to-infant transmission rate of hepatitis B as the proportion of infants who are HBsAg positive and have serum HBV DNA \>20 IU/mL at 28 weeks of age among all live births in the experimental group. Additionally, this study will also compare the incidence of congenital defects/malformations in infants born to mothers treated with tenofovir alafenamide and tenofovir disoproxil fumarate during the perinatal period to assess drug safety.

The purpose of the Antiretroviral Pregnancy Registry (Registry) is to detect any major teratogenic effect involving any of the Registry drugs when administered to pregnant people. Registration is voluntary and confidential with information obtained from the health care provider. A Registry-assigned identifier allows for follow-up capability. Information on subjects is provided to the Registry prospectively (prior to the outcome of pregnancy being known) through their health care provider, with follow-up obtained from the health care provider after the outcome is determined. Providers are strongly urged to enroll their patients as early in pregnancy as possible to maximize the validity of the data. In addition, the Registry is very interested in assembling a group of providers who are willing to make a commitment to report all of their site's antiretroviral pregnancy exposures to the Registry, thereby assuring all cases can be considered prospective. Providers are encouraged to contact the Registry for more information about this group. The Registry is informed in its analysis by other data, for example, retrospective reports and clinical studies. Given the increasing number of medications and more aggressive approach to therapy, more HIV- and hepatitis B-infected people may be treated during pregnancy or become pregnant while under treatment. The paucity of data on use and infant outcomes of antiretroviral therapies during pregnancy makes this Registry an essential component of the ongoing program of epidemiologic studies of the safety of these therapies. Each year the Registry has enrolled approximately 1300-1700 pregnant people in the US exposed to antiretroviral drugs. This number represents approximately 15% of the 8,700 HIV positive people who give birth to live infants annually in the US.

As part of the CE marking of a hepatitis B diagnostic kit, the South Korean manufacturer Bioneer wishes to set up a performance study in France in accordance with the IVDR (RE 2017/746). Cerba Xpert CRO of the Cerba Healthcare group promoted this performance study by setting up a prospective collection of blood samples from patients with hepatitis B virus and whose viral load is positive. This prospective collection will be carried out in 3 laboratories of the Cerba Healthcare group.

This prospective cohort study aims to provide the evidence-based clinical guide to help decide the revaccination doses of hepatitis B vaccine that the high-risk young adults without hepatitis B seroprotective antibodies (anti-HBs titer\<10 mIU/mL) need to take.

This study will be conducted to investigate the effects of hot foot baths on patients' sleep quality and fatigue severity levels.The study will be conducted in the Gastroenterology clinic of a university hospital in Türkiye. The research sample will consist of 60 adult patients. Patients will be randomly divided into two groups: the intervention and control groups. The intervention group will receive hot foot baths for three consecutive nights starting from the second day of hospitalization. The foot bath will be applied one hour before the patient goes to bed at night. The foot tub will be filled with hot water to approximately 20 cm above the patient's ankle and the temperature of the water will be measured with a water thermometer. The temperature of the water will be kept stable at 41-42°C. This application will be done for 20 minutes. The sleep and fatigue levels of the patients will be measured with measurement tools in the morning (3 times) following each application. No application will be applied to the control group, and sleep and fatigue levels will be measured in a similar manner to the measurement tools applied to the intervention group and the application days.