[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aligos Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100590153","phase-2-a-study-evaluating-the-efficacy-and-safety-of-alg-000184-compared-with-tenofovir-disoproxil-fumarate-in-untreated-hbeag-positive-and-hbeag--negative-adult-subjects-with-chronic-hepatitis-b-b-supreme-100590153",false,"NCT06963710","A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)","A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg-Negative Adult Subjects With Chronic Hepatitis B Virus Infection (B-SUPREME)","B-SUPREME","Key Inclusion Criteria:\n\n1. Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg\u002Fm2 (or minimun age by local regulatory requirements).\n2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).\n3. HBsAg ≥LLOQ.\n4. HBV DNA ≥20,000 IU\u002FmL.\n5. A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.\n6. Must have the following chronic hepatitis B virus infection treatment status at screening:\n\n   1. Have never received treatment with HBV antiviral medicines (NA, interferon) or investigational anti-HBV agents including a CAM \\[i.e., Treatment Naïve (TN) subjects\\], OR\n   2. Have not been on treatment with approved (NA, interferon) or investigational HBV antiviral medicines (e.g., antisense oligonucleotides or small interfering RNAs) within 6 months or 5 half-lives (whichever is longer) prior to randomization (i.e., Currently Not Treated (CNT) subjects).\n\nKey Exclusion Criteria:\n\n1. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.\n2. Positive for anti-HBs antibodies.\n3. History or current evidence of cirrhosis.\n4. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.\n5. History of, or current evidence of, hepatic decompensation.\n6. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.\n7. Having received an investigational medicinal product or device within 4 weeks (or 5 half-lives, whichever is longer) before the planned first dose of study drug\n8. Exclusionary screening laboratory values include:\n\n   1. Aspartate aminotransferase (AST) \\>8×ULN,\n   2. Bilirubin (total, direct) \\>1.2×ULN (unless Gilbert's syndrome is suspected)\n   3. International Normalization Ratio (INR) \\>1.2×ULN","ALL","18 Years","65 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a Phase 2 study to evaluate efficacy and safety of 48 weeks of oral once daily monotherapy with ALG-000184 versus tenofovir disproxil fumarate (TDF) for chronic HBV infection.",[28],"Chronic Hepatitis B Infection",[30,31,32,33,34,35,36],"Capsid Assembly Modulators","CAMs","CHB","HBV","Chronic Hepatitis B","Hepatitis B Infection","Hepatitis B","RECRUITING","2026-04-29",{"date":40,"type":41},"2026-05-01","ACTUAL",{"date":43,"type":41},"2025-07-15",{"date":45,"type":22},"2028-08",{"name":47,"class":48},"Aligos Therapeutics","INDUSTRY",58,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100619304","phase-1-single-dose-study-to-evaluate-the-pharmacokinetics-safety-and-tolerability-of-pevifoscorvir-sodium-alg-000184-in-participants-with-renal-impairment-and-in-healthy-participants-with-normal-renal-function-100619304","NCT07342881","Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function","A Phase 1 Non-Randomized, Open-Label, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function","Inclusion Criteria for All Subjects:\n\n1. Male and Female between 18 and 75 years old\n2. Body Mass Index (BMI) 17.5 to 40.0 kg\u002Fm\\^2 and a total body weight \\>50 kg (110 lb)\n3. Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any non-sterile, male sexual partners agree to use highly effective contraceptive therapy\n\nInclusion Criteria for Subjects with Normal Renal Function:\n\n1. Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs, clinical laboratory and 12-lead electrocardiogram (ECG) assessment\n2. Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, sex\n3. Normal renal function (estimated Glomerular Filtration Rate \\[eGFR\\] ≥90 mL\u002Fmin) with no known or suspected renal impairment\n\nInclusion Criteria for Subjects with Impaired Renal Function:\n\n1. Subject satisfies the eGFR criteria for renal impairment classification within 28 days of study drug administration\n2. Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).\n3. Stable concomitant medications for the management of an individual subject's medical history for at least 28 days prior to screening\n4. Subjects must have a 12-lead ECG and vital signs assessment that meet the protocol criteria\n\nExclusion Criteria for All Subjects:\n\n1. Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results and interpretation\n2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or recent history or clinical evidence at screening of significant (subjects with normal renal function) or unstable (subjects with renal impairment) cardiac disease etc.\n3. Subjects with a history of clinically significant drug allergy\n4. Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use\n5. Excessive use of alcohol defined as regular consumption of ≥14 units\u002F week for women and ≥21 units\u002Fweek for men\n6. Unwilling to abstain from alcohol use for 48 hours prior to start of the study through end of study follow up\n7. Subjects with Hepatitis A, B, C, E or HIV-1\u002FHIV-2 infection or acute infections such as SARS- CoV-2 infection\n8. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \\>2x upper limit of normal (ULN)\n9. Subjects with bilirubin (total, direct) \\>1.5x ULN (unless Gilbert's is suspected)\n10. Positive pregnancy test; females must not be pregnant at enrollment\n\nExclusion Criteria for Subjects with Normal Renal Function:\n\n1\\. Hemoglobin \\\u003C10 g\u002FdL\n\nExclusion Criteria for Subjects with Impaired Renal Function:\n\n1. Participants requiring hemodialysis and\u002For peritoneal dialysis\n2. Hemoglobin \\\u003C9 g\u002FdL",true,"75 Years",{"count":60,"type":22},30,[62],"PHASE1","This is a Phase 1 non-randomized, open-label, single-dose study of pevifoscorvir sodium (also known as ALG-000184) in participants with severe renal impairment (Part 1), in participants with mild or moderate renal impairment (Optional Part 2) and in participants without renal impairment (Parts 1 and 2), matched for age, body weight and, to the extent possible, for sex.",[28],[28],"2026-02-26",{"date":68,"type":41},"2026-02-27",{"date":70,"type":41},"2026-02-20",{"date":72,"type":22},"2026-07-01",{"name":47,"class":48},2,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100619303","phase-1-single-dose-study-to-evaluate-the-pharmacokinetics-safety-and-tolerability-of-pevifoscorvir-sodium-alg-000184-in-subjects-with-moderate-hepatic-impairment-and-in-healthy-subjects-with-normal-hepatic-function-100619303","NCT07342868","Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function","A Phase 1 Non-Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety- and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function","Inclusion Criteria:\n\n1. Male and Female between 18 and 75 years old\n2. BMI 17.5 to 40.0 kg\u002Fm\\^2 and a total body weight \\>50 kg (110 lb)\n3. Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any non- sterile, male sexual partners agree to use highly effective contraceptive therapy\n4. Female subjects must have a negative serum pregnancy test at screening\n\nInclusion Criteria for Subjects with Normal Hepatic Function:\n\n1. Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs and 12-lead electrocardiogram (ECG) assessment\n2. Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, gender\n3. Normal hepatic function with no known or suspected hepatic impairment\n\nInclusion Criteria for Subjects with Impaired Hepatic Function:\n\n1. Subject satisfies the criteria for Class B of the Child-Pugh classification (Child Pugh Scores 7-9 points) within 28 days of study drug administration\n2. A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound, Fibroscan, computerized tomography scan, or magnetic resonance imaging (MRI)\n3. Stable hepatic impairment for at least 3 months prior to screening or second screening visit to demonstrate stability\n4. Stable concomitant medications for the management of an individual subject's medical history for at least 28 days prior to screening Subjects must have a 12-lead ECG and vital signs assessment that meet the protocol criteria\n\nExclusion Criteria for All Subjects:\n\n1. Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation\n2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.\n3. Subjects with a history of clinically significant drug allergy\n4. Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use\n5. Excessive use of alcohol defined as regular consumption of ≥14 units\u002F week for women and ≥21 units\u002Fweek for men\n6. Unwilling to abstain from alcohol use for 48 hours prior to start of the study through end of study follow up\n7. Subjects with Hepatitis A, B, C, E or HIV-1\u002FHIV-2 infection or acute infections such as SARS- CoV-2 infection. Subjects provided they met stable treatment criteria. Subjects with HIV infection may be eligible for moderate impairment cohort provided they met stable treatment criteria.\n\nExclusion Criteria for Subjects with Normal Hepatic Function:\n\n1. Estimated creatinine clearance \\\u003C60 mL\u002Fmin\u002F1.73 m2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula\\] - Unless otherwise instructed by the Study Review Committee (SRC), CKD-EPI should not be corrected for subjects of African ancestry\n2. Bilirubin (total, direct) \\>1.2× upper limit of normal (ULN) (unless Gilbert's is suspected)\n3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level \\> 1.2×ULN\n4. Grade ≥1 Hemoglobin\n\nExclusion Criteria for Subjects with Impaired Hepatic Function:\n\n1. Subjects with advanced ascites (Grade 3)\n2. Subjects with refractory encephalopathy as judged by the investigator.\n3. Subjects with esophageal variceal bleeding within the past 6 months prior to screening.\n4. Subjects with Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement.\n5. Estimated creatinine clearance \\\u003C60 mL\u002Fmin\u002F1.73 m2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula\\] - Unless otherwise instructed by the SRC, CKD-EPI should not be corrected for subjects of African ancestry\n6. ALT or AST level ≥5×ULN\n7. Serum sodium ≤125 mmol\u002FL\n8. Platelets \\\u003C50×10\\^9\u002FL\n9. Grade ≥2 Hemoglobin",{"count":83,"type":22},16,[62],"This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment (Cohort 2), matched for age, body weight and, to the extent possible, for sex. The effect of hepatic impairment on the plasma pharmacokinetics of ALG-001075 will be assessed in subjects who have received single oral doses of pevifoscorvir sodium (ALG-000184).",[87],"Chronic Hepaititis B Infections",[87],"2026-02-02",{"date":91,"type":41},"2026-02-04",{"date":93,"type":41},"2026-01-30",{"date":95,"type":22},"2026-05-05",{"name":47,"class":48},1,""]