[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hdv-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hdv-infection":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,80,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100626986","epro-diary---hdv--macroliver--100626986",false,"NCT07442760","ePro Diary - HDV ( MACROLIVER )","The Patient is the Main Protagonist of His Care Journey","Inclusion Criteria:\n\n* Age \\> 18 years\n* Diagnosis of Delta infection (anti-HDV positivity)\n* Signed informed consent\n* Ability to adequately understand instructions for correctly using mobile device applications.\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent.","ALL","18 Years",{"count":19,"type":20},55,"ESTIMATED","OBSERVATIONAL","This study is part of the MACROLIVER Project, which aims to develop a digital tool for patients and their caregivers to manage liver diseases. Approximately 20-25 million individuals worldwide carry HBsAg and are co-infected with HDV, though geographic variations exist. In Italy, an estimated 10,000-20,000 individuals are affected by Delta hepatitis (HD). These data are approximate, given the absence of current population studies and effective screening methods.\n\nAlthough considered rare, chronic HD (CHD) is the most aggressive form of viral hepatitis, with most patients progressing rapidly to end-stage liver disease or developing hepatocellular carcinoma at a young age, often requiring liver transplantation. Screening HBsAg-positive patients for Delta co-infection is not widespread, leading to late diagnoses. Additionally, accurate quantification of viral RNA is limited to a few specialized centers.\n\nThe lack of effective antiviral therapies has led many Delta hepatitis patients to frequently switch hepatology centers in search of treatments or to miss regular medical check-ups. However, HDV management may change significantly following the recent EMA approval of a new antiviral drug, bulevirtide-an entry inhibitor administered subcutaneously daily-reimbursed in Italy since April 2023. This drug has shown promising results in Phase II and III studies, including in cirrhotic patients with severe portal hypertension.\n\nThe COVID-19 pandemic exacerbated this situation, causing reduced access to healthcare facilities and negatively impacting patients with chronic diseases. However, it also accelerated the search for effective, high-quality digital solutions for patient management.\n\nThe ePro-Diary HDV proposes to facilitate continuous communication between patients and doctors, monitor key lab values, quality of life questionnaires, and overall health status by an application for mobile phone.\n\nThe objectives are twofold: to make patients active participants in their care-enhancing retention and adherence through an \"active App-based approach\"-and to evaluate changes in patient quality of life with this \"active\" remote approach. This tool will support clinicians and patients without replacing standard clinical monitoring.",[24,25,26],"HDV","HDV Infection","Hepatitis","RECRUITING","2026-02-24",{"date":30,"type":31},"2026-03-02","ACTUAL",{"date":33,"type":31},"2025-03-31",{"date":35,"type":20},"2030-03-31",{"name":37,"class":38},"FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":51,"conditions":52,"keywords":57,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":39},"100624695","pregnancy-and-viral-infections-impact-on-pregnant-women-and-their-children-french-prospective-cohort-100624695","NCT07412977","\"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort\"","\"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort.\"","VIROPREG","Inclusion Criteria:\n\nPregnant women :\n\n* Cis-gender pregnant woman wishing to carry her pregnancy to term and give birth in one of the maternity units participating in the research, whatever the term of pregnancy (inclusion as soon as possible after conception, whatever the outcome);\n* Age ≥18 years;\n* Viral infection studied known before pregnancy or diagnosed during pregnancy;\n* Signed, free, informed and written consent;\n* Be cared for in one of the maternity units taking part in the study\n\nNewborns\u002Fchildren:\n\n\\- Free, informed, written and signed consent of parental guardians.\n\nExclusion Criteria:\n\nPregnant women :\n\n* Planned delivery in a non-study center;\n* Planned absence that could hinder participation in the research;\n* Vulnerable population (minors, persons under guardianship or trusteeship, or persons deprived of their liberty by judicial or administrative decision);\n* Level of French oral comprehension insufficient according to the investigator for the research process understanding\n\nNewborns\u002Fchildren:\n\n* Refusal of parental authority to allow newborn\u002Fchild to participate in study\n* Follow-up of the child planned in a center not participating in the study\n* Scheduled absence of parents that could hinder the child's participation in the study;","FEMALE",{"count":50,"type":20},5160,"The VIROPREG study is a French prospective multicenter cohort study that aims to assess the impact of viral infections and antiviral treatments received during pregnancy on maternal and child health. The study focuses on both chronic viral infections: human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV)\\] and on arbovirus infections.\n\nThis study aims at investigating the following research questions:\n\n* What is the rate of mother-to-child transmission for each virus?\n* What are the effects of maternal infection on (i) pregnancy outcomes, (ii) the mother's physical and psychological health, and (iii) the fetus' health and development, with a focus on long-term psychomotor development in children born to women living with HIV?\n* What is the impact of antiretroviral and\u002For antiviral prophylactic and\u002For therapeutic treatments administered during pregnancy on maternal and fetal health? Mother-child pairs will be followed from pregnancy through delivery and from birth until the child reaches 7 years of age. Each mother-child pair will be enrolled into one of four cohort groups based on the maternal infection.\n\nHIV Cohort:\n\nPregnant women living with HIV who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6-8 weeks post-partum)\n* Participate in additional follow-up by phone call or videoconference at 4- and 7-years post-partum for research purposes\n* Complete questionnaires at inclusion, delivery, 4- and 7- years postpartum\n* In case of breastfeeding, receive follow-up care aligned with routine schedules for up to 2 years postpartum, including 2 additional visits specifically for research at 2- and 3- months postpartum.\n* In selected cases: provide blood, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes (pharmacological and virological analyses).\n\nChildren born to mothers living with HIV and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth until 2 years of age\n* Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.\n\nHBV Cohort:\n\nPregnant HBV-infected women who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6- 8 weeks post-partum)\n* Complete questionnaires at inclusion and delivery\n* Provide blood samples during follow-up visits for research purposes.\n\nChildren born to HBV-infected mothers and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth to 2 years of age\n* Participate in additional follow-up for research purposes at 3 months and 18-24 months of age.\n\nHCV Cohort:\n\nPregnant HCV-infected women who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6 - 8 weeks post-partum)\n* Complete questionnaires at inclusion and delivery\n* Provide blood samples during follow-up visits for research purposes.\n\nChildren born to HCV-infected mothers and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth until 2 years of age\n* Attend additional follow-up visits scheduled at 3 and 9 months of age for research purposes.\n\nArbovirus Cohort:\n\nPregnant women infected with arbovirus who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to delivery\n* Participate in additional follow-up for research purposes at 4 years after delivery.\n* In case of breastfeeding, women will be monitored for research purposes at Day 7 and Day 30 postpartum\n* Complete questionnaires at inclusion, Day 7-10 from the inclusion, delivery and 4 years after delivery\n* Provide blood, amniotic fluid, placenta, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes.\n\nChildren born to mothers infected with arbovirus and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth until 2 years of age.\n* Participate in additional follow-up for research purposes at inclusion, Day 7 and Day 30 after inclusion\n* Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.",[53,54,25,55,56],"HIV Infection","HBV Infection","HCV Infection","Arbovirus Infections",[58,59,60,61,62,63,64,65,66,67,68,26],"Pregnancy","HIV","HBV","HCV","Arbovirus","National health data system","Neurocognitive disorders","Quality of life","Pregnancy viral infections","Mother-to-child transmission","Social epidemiology","NOT_YET_RECRUITING","2026-02-09",{"date":72,"type":31},"2026-02-17",{"date":74,"type":20},"2026-02",{"date":76,"type":20},"2039-12",{"name":78,"class":79},"ANRS, Emerging Infectious Diseases","OTHER_GOV",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100617033","10119473--viromarkers-hdv-biomarkers-study-100617033","NCT07313358","10119473 -VIROMARKERS HDV Biomarkers Study","Inclusion Criteria:\n\n* Be \\> 18 years of age\n* Sign an informed consent\n* Have a diagnosis of HDV infection with or without compensated cirrhosis\n* Having started BLV monotherapy 2mg\u002Fday according to the criteria reported in the recent clinical practice guidelines on HDV infection promoted by EASL (EASL CPG 2023)\n* Be under effective treatment with nucleoside analogues with HBV-DNA \\\u003C20 IU\u002Fml at the time of starting BLV\n\nExclusion Criteria:\n\n* Decompensated liver disease\n* BLV combined with pegIFN\n* Past treatment with BLV",{"count":87,"type":20},220,"This is an observational study, in which clinical data, samples, and any other procedures possibly already performed on participants, were performed within the scope of clinical practice or within the scope of otherwise authorized projects, and that therefore there are no procedures performed specifically for this study, which instead uses data collected previously or prospectively during an extended follow-up, but in any case within the scope of current clinical practice. Most participants have been enrolled and followed up at the project partners' clinical sites over 2023-2025. Their follow-up and sample collection will continue over the duration of the project. At the time of enrollment, demographics, medical history, medications and treatments prescribed were recorded and will be used in this study if the participant consent to be included also in VIROMARKERS. HDV genotypes\u002Fsubgenotypes will be determined ex-novo on existing baseline stored samples.\n\nThe harmonization of HDV-RNA assays by utilizing standardized and validated flowcharts still represents a relevant diagnostic unmet clinical need for the appropriate monitoring of patients with CHD receiving BLV treatment. Furthermore, information on long-term virological response and factors predictive of virological outcome is scarce.\n\nSpecific primary objectives to characterise the response to bulevirtide in CHD include:\n\n* To estimate the percentage of participants who will achieve virological response (defined as a decline in serum HDV RNA of \\>2 log or to undetectable HDV-RNA) and the proportion achieving undetectable HDV-RNA at week 48, 96 and 144 weeks of BLV treatment.\n* To estimate the percentage of participants who will achieve biochemical response and combined response (defined as achievement of virological response and ALT normalization) at week 48, 96 and 144 weeks of BLV treatment.\n* To evaluate whether HDV-RNA levels at baseline or their kinetics during the first 12 weeks of BLV treatment can predict the achievement of undetectable serum HDV-RNA during BLV treatment.",[25],[91,92,93],"HDV infection","bulevirtide","biomarkers","2026-01-19",{"date":96,"type":31},"2026-01-22",{"date":98,"type":20},"2026-02-20",{"date":100,"type":20},"2026-10-30",{"name":102,"class":38},"University of Rome Tor Vergata",2,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":113,"studyType":21,"phases":4,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":5},"100528427","d-solve-cohorts-cohort-a-and-b-100528427","NCT06160635","D-SOLVE Cohorts (Cohort a and B)","HDV750","Inclusion Criteria:\n\n* Anti-HDV positive\n* ≥18 years old\n* Sex: m\u002Ff\u002Fd\n* Informed consent for prospective procedures\n\nExclusion Criteria:\n\n* Anti-HDV negative",{"count":112,"type":20},750,"3 Years","Hepatitis D is by far the most severe form of chronic viral hepatitis, frequently leading to liver failure, hepatocellular carcinoma and death. Hepatitis D is caused by coinfection Hepatitis D is caused by co-infection with hepatitis B virus (HBV) and hepatitis D virus (HDV).\n\nThis multicenter cohort should enable a comprehensive and unbiased biomarker screening of well-defined HDV-infected patients, followed by mechanistic studies to determine the functional role of distinct molecules. Patient surveillance strategies and antiviral treatment approaches could be personalized which should reduce clinical and social disease burden, improve quality of life and save direct and indirect costs caused by HDV infection.",[24,25,116],"Chronic Liver Disease",[24,118,119,120,121],"Hepatitis Delta","chronic liver disease","patient cohort","biomarker","2025-03-11",{"date":124,"type":31},"2025-03-12",{"date":126,"type":31},"2023-02-22",{"date":128,"type":20},"2026-09-30",{"name":130,"class":38},"Hannover Medical School"]