[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646200":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":41,"locations":46,"responsibleParty":61,"collaborators":64,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":91,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"National University Health System, Singapore","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants on Nucleoside Analogue treatment","EXPERIMENTAL","Participants on NA treatment at screening will go through the following stages:\n\n* 1st Liver Biopsy at baseline\n* 2nd Liver Biopsy during therapy\n* 3rd Liver Biopsy (optional)",[13,14,15],"Drug: Bepirovirsen","Procedure: Liver biopsy","Procedure: Optional Liver biopsy",{"label":17,"type":10,"description":18,"interventionNames":19},"Participants not on Nucleoside Analogue treatment","Participants not on NA treatment at screening will go through the following stages\n\n* 1st Liver Biopsy\n* 2nd Liver Biopsy during therapy\n* 3rd Liver Biopsy (optional)",[13,14,15],[21,27,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bepirovirsen","Weekly Bepirovirsen treatment for 24 weeks, with loading doses",[17,9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Liver biopsy","Liver biopsy as previously described",[17,9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"Optional Liver biopsy","An optional Liver biopsy as previously described",[17,9],[37],{"name":38,"affiliation":39,"role":40},"Seng Gee Prof Lim, Professor","Division of Gastroenterology & Hepatology, National University Hospital (NUH)","PRINCIPAL_INVESTIGATOR",[42],{"name":38,"role":43,"phone":44,"phoneExt":26,"email":45},"CONTACT","+6567724369","mdclimsg@nus.edu.sg",[47],{"facility":39,"status":26,"city":48,"state":26,"zip":49,"country":48,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Singapore","119074","SG",{"type":52,"coordinates":53},"Point",[54,55],103.85007,1.28967,{"lat":55,"lon":54},[58,60],{"name":38,"role":43,"phone":44,"phoneExt":26,"email":59},"mdclim@nus.edu.sg",{"name":38,"role":40,"phone":26,"phoneExt":26,"email":26},{"type":40,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Seng Gee Lim","Prof",[65,67],{"name":66,"class":6},"A*Star",{"name":68,"class":6},"National University of Singapore","100646200","phase-2-bepirovirsen-liver-biopsy-study-100646200",false,"NCT07696520","Bepirovirsen Liver Biopsy Study","GSK Biopsy","Inclusion Criteria:\n\n1. At least 21 years of age at the time of signing the informed consent.\n2. Documented to be HBsAg positive for ≥ 6 months prior to Screening.\n3. Currently receiving stable NA therapy (defined as no changes to their NA regimen from at least 6 months prior to Screening and with no planned changes to the stable regimen over the duration of the study), or not receiving any Hepatitis B treatment for at least 6 months, or Hepatitis B treatment naïve.\n4. qHBsAg ≤1000 IU\u002Fml\n5. Alanine aminotransferase (ALT) ≤2x ULN\n6. A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:\n\n   * Is a woman of non-childbearing potential\n   * Is a woman of childbearing potential and using a contraceptive method\n7. Capable of giving signed informed consent\n\nExclusion Criteria:\n\n1. qHBsAg \\> 1000 IU\u002Fml\n2. Do not consent to participate in the Bepirovirsen Liver Biopsy study\n3. Clinically significant abnormalities or clinically significant physical examination findings (e.g. major surgery within 3 months of screening)\n4. Past history of or current co-infection with Hepatitis C infection, Human immunodeficiency virus (HIV) or Hepatitis D virus\n5. History of or liver cirrhosis as determined by:\n\n   1. Fibroscan \\> 12kPa\n   2. Participant's historic record of either\u002Fboth liver biopsy or liver stiffness measurements in their medical records where their results are Liver biopsy Metavir Score is F4, they will be excluded from the study(If the participant has inconsistent clinical picture of cirrhosis, confirm and discuss eligibility with an investigator)\n6. Diagnosed with hepatocellular carcinoma as evidenced by Alpha-fetoprotein concentration ≥200 ng\u002FmL or if the screening alpha fetoprotein concentration is ≥50 ng\u002FmL and \\\u003C200 ng\u002FmL, the absence of liver mass must be documented by imaging within 6 months of or at screening. Cases should be discussed with an investigator.\n7. History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible.\n8. History of vasculitis or presence of symptoms and signs of potential vasculitis, current or history of an autoimmune condition or history\u002Fpresence of other diseases that may be associated with vasculitis condition\n9. History of extrahepatic disorders possibly related to HBV immune conditions\n10. Current\u002FHistory of alcohol or drug abuse\u002Fdependence as judged by the investigator to potentially interfere with participant compliance\n11. Currently taking, or took within 3 months of screening, any immunosuppressing drugs, other than a short course of therapy (≤2 weeks) or topical\u002Finhaled steroid use.\n12. Participants requiring anti-coagulation therapies or anti-platelet agents unless treatment can safely be discontinued throughout duration of Bepirovirsen treatment, by the discretion of the investigator. Occasional use is permitted.\n13. The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives (if known) or twice the duration (if known) of the biological effect of the study treatment (whichever is longer) or 90 days (if half-life or duration is unknown).\n14. Prior treatment with any oligonucleotide or siRNA within 12 months prior to the first dosing day\n15. Prior treatment with Bepirovirsen within 6 months\n16. Fridericia's QT correction formula (QTcF) ≥450 msec (if single ECG at screening shows QTcF ≤450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion).\n17. Laboratory results as follows:\n\n    1. Serum albumin ≤3.5 g\u002FdL\n    2. Glomerular filtration rate (GFR) ≤60 mL\u002Fmin\u002F1.73m2 as calculated by the CKD-EPI formula\n    3. INR \\>1.25\n    4. Platelet count \\\u003C140 x 109\u002FL\n    5. Total bilirubin \\>1.25x ULN (For participants with benign unconjugated hyperbilirubinemia with total bilirubin \\>1.25x ULN, discussion for inclusion to the study is required with the investigator)\n    6. Urine albumin to creatinine ratio (uACR) \\>0.3 mg\u002Fmg (or \\>300 mg\u002Fg). (In the event of an uACR above this threshold, eligibility may be confirmed by a second measurement. In cases where results are shown as unable to perform (UTP), please check the individual labs and confirm that the participant has urine albumin and\u002For urine creatinine within normal levels. The investigator should confirm that the participant does not have a history of medical conditions or other risk factors that may affect renal function)\n18. History of\u002Fsensitivity to Bepirovirsen or components thereof or a history of drug or other allergy that, in the opinion of the investigator, contraindicates their participation.","ALL","21 Years",{"count":79,"type":80},30,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","Bepirovirsen Liver Biopsy study is a single centre open label phase II study to examine the antiviral and immunological effects of bepirovirsen in CHB patients both treated and untreated with HBsAg\\\u003C1000 IU\u002Fml",[86,87],"HEPATITIS B CHRONIC","Hepatitis B Chronic Infection",[89,23,90],"hepatitis B","Liver Biopsy","NOT_YET_RECRUITING","2026-07-06",{"date":94,"type":95},"2026-07-10","ACTUAL",{"date":97,"type":80},"2026-07-01",{"date":99,"type":80},"2028-04-30",{"name":5,"class":6},1]