[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GC Biopharma Corp\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":141},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,68,92,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100597100","phase-3-a-study-to-evaluate-immunogenicity-and-safety-after-the-first-and-second-doses-of-mg1111-barycela-inj-in-healthy-children-aged-12-months-to-12-years-100597100",false,"NCT07054099","A Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years","A Phase III, Double-blind, Randomized, Multicenter, Multinational, Active-controlled, Non-inferiority Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years","Inclusion Criteria:\n\n* Participant must be 12 months to 12 years of age, inclusive, at the time of signing the informed consent or assent.\n* Participant is overtly healthy as determined by the investigator\n\nExclusion Criteria:\n\n* Participants with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before Screening\n* Participants with a history of varicella infection and varicella vaccine, either licensed or investigational, and either standalone or any combination, such as MMRV\n* Participants with acute moderate or severe infection with or without fever at the time of dosing\n* Participants who have had any suspected allergy symptoms, such as systemic rash, during the 72 hours before each administration of investigational product",true,"ALL","12 Months","12 Years",{"count":21,"type":22},474,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This clinical study aims to evaluate the safety and immune response of MG1111, in healthy children compared to VARIVAX. The study will follow participants for 42 days after receiving two doses, with additional follow-ups for up to 10 years to monitor varicella infection.",[28,29],"Varicella (Chickenpox)","Chickenpox Vaccine","RECRUITING","2026-04-14",{"date":33,"type":34},"2026-04-17","ACTUAL",{"date":36,"type":34},"2026-03-17",{"date":38,"type":22},"2036-07",{"name":40,"class":41},"GC Biopharma Corp","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100582060","phase-1-a-proof-of-concept-study-to-assess-safety-and-tolerability-of-hm15421gc1134a-in-patients-with-fabry-disease-100582060","NCT06858397","A proof-of Concept Study to Assess Safety and Tolerability of HM15421\u002FGC1134A in Patients With Fabry Disease","An Open Label, Dose Range, Proof-of-Concept Study to Assess the Safety and Efficacy of HM15421\u002FGC1134A in Patients With Fabry Disease","Inclusion Criteria:\n\n1. Participants must be ≥ 18 years of age or age considered as adult in the respective country at the time of signing the informed consent.\n2. Documented diagnosis of FD with clinical symptoms.\n3. Females: historical genetic test results based on identification of pathogenic or likely pathogenic GLA variant of FD.\n4. Males: Plasma and\u002For leucocyte alpha galactosidase activity (by activity assay) less than lower limit of normal (LLN in plasma=3.2 nmol\u002Fhr\u002FmL, LLN in leucocytes=32 nmol\u002Fhr\u002Fmg\u002Fprotein).\n5. Patients who are naive or have not received FD therapy including investigational therapy for FD within the past 6 months prior to screening and have negative ADA testing at screening.\n6. Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n7. Plasma lyso-Gb3 levels greater than 1.5 times the upper limit of normal (ULN).\n8. Male participants:\n\n   * Male participants are eligible to participate if they agree to the following during the study treatment period:\n   * Refrain from donating sperm,\n\n   PLUS either:\n   * Be abstinent from heterosexual intercourse with a woman of childbearing potential (WOCBP) as their preferred and usual lifestyle (abstinent on a longterm and persistent basis) and agree to remain abstinent, OR\n   * Must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person,\n   * In addition to male condom, use of highly effective method of contraception may be considered in WOCBP partners of male participants.\n9. Female participants:\n\n   * Female participants are eligible to participate if they are not pregnant or breastfeeding, and at least 1 of the following conditions applies:\n\n     * Is not a WOCBP, OR\n     * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year), preferably with low user dependency, starting at least one menstrual cycle before first study drug administration and continuing for at least 30 days after the end of systemic exposure of the study drug and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study drug.\n     * A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study drug.\n     * If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n   * Women whose postmenopausal status is recent, may perform additional follicle stimulating hormone (FSH) testing.\n\n   Informed Consent\n10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n1. Women who are pregnant, planning to become pregnant during the study, or are breast feeding.\n2. History of dialysis or renal transplantation.\n3. CKD stage ≥ 3.\n4. History of acute kidney injury within 12 months prior to screening, including specific kidney diseases (eg, acute interstitial nephritis, acute glomerular and vasculitic renal diseases); non-specific conditions (eg, ischemia, toxic injury); as well as extrarenal pathology (eg, prerenal azotemia, and acute postrenal obstructive nephropathy).\n5. Urine protein to creatinine ratio (UPCR) \\> 0.5 g\u002Fg and not treated with an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).\n6. Known history of hypersensitivity to any ingredient in the investigational product and to Gadolinium contrast agent that is not managed by the use of premedication.\n7. Cardiovascular event (myocardial infarction, unstable angina) within 6 months before screening.\n8. Congestive heart failure New York Heart Association (NYHA) Class IV\n9. History of stroke.\n10. Pacemaker or other contraindication for magnetic resonance imaging (MRI) scanning.\n11. Angiotensin converting enzyme inhibitor or ARB therapy initiated or dose changed in the 4 weeks prior to screening.\n12. Patients who received investigational gene therapy for FD.\n13. Participation in other studies involving study drugs within 4 weeks prior to study entry and\u002For during study participation.\n14. Participating in interventional study or using compassionate access product for FD. Participants who have participated in interventional trials for conditions not related to FD should be enrolled after the adequate wash out period is over, which is 5 half-lives or 30 days whichever is longer.\n15. Presence of human immunodeficiency virus (HIV) and\u002For active (acute or chronic) hepatitis B and\u002For Hepatitis C infections.\n16. Presence of any medical, emotional, behavioral, or psychological condition that, in the judgment of the Investigator and\u002For Medical Monitor, would interfere with the participant's compliance with the requirements of the study.\n17. Participants who may have history of deliberate self-harm or suicidal ideation.","18 Years",{"count":52,"type":22},18,[54,55],"PHASE1","PHASE2","This Phase 1\u002F2 first-in-human (FIH) study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15421 in patients with FD.",[58],"Fabry Disesase","2025-11-02",{"date":61,"type":34},"2025-11-04",{"date":63,"type":34},"2025-05-14",{"date":65,"type":22},"2028-08-30",{"name":40,"class":41},10,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":5},"100559717","phase-1-phase-1-study-of-gc1130a-in-patients-with-sanfilippo-syndrome-type-a-mps-iiia-100559717","NCT06567769","Phase 1 Study of GC1130A in Patients With Sanfilippo Syndrome Type A (MPS IIIA)","A Phase 1, Open-label, Ascending Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Recombinant Human Heparan N-Sulfatase (rhHNS, GC1130A) Via Intracerebroventricular Access Device in Patients With Sanfilippo Syndrome Type A (MPS IIIA)","Inclusion Criteria:\n\n* Participants with documented MPS IIIA diagnosis\n* Participants aged ≥ 12 months and ≤ 18 years\n\nExclusion Criteria:\n\n* Participants with significant non-MPS IIIA related central nervous system impairment\n* Participants with previous complication from intraventricular drug administration\n* Participants with contraindications for MRI scans and for neurosurgery\n* Participants that received treatment with any investigational drug or a device intended as a treatment for MPS IIIA within 30 days or 5 half-lives prior to the study\n* Participants that received a hematopoietic stem cell or bone marrow transplant or received gene therapy",{"count":76,"type":22},9,[54],"The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of recombinant human heparan N-sulfatase (rhHNS, GC1130A) administered via intracerebroventricular access device in patients with Sanfilippo Syndrome Type A (MPS IIIA).",[80],"Sanfilippo Syndrome Type A",[82,83],"Mucopolysaccharidosis Type III Subtype A","MPS IIIA","2025-08-21",{"date":86,"type":34},"2025-08-28",{"date":88,"type":34},"2024-11-21",{"date":90,"type":22},"2027-06",{"name":40,"class":41},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":16,"sex":17,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":42},"100592760","phase-1-a-phase-iii-study-to-evaluate-the-safety-and-immunogenicity-of-gc3111b-in-healthy-adults-100592760","NCT06997627","A Phase I\u002FII Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults","An Open(Part 1), Single-arm(Part 1), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Phase I\u002FII Clinical Trial to Evaluate the Safety and Efficacy (Immunogenicity) of GC3111B in Healthy Adults","Inclusion Criteria:\n\n* Healthy adults aged 19 to 64 years old as of the date of written consent.\n* Individuals with no history of vaccination with a vaccine containing diphtheria, tetanus, or pertussis antigens within the past 2 years prior to administration of the investigational product.\n\nExclusion Criteria:\n\n* Individuals who have received a vaccine within 4 weeks prior to administration of the investigational product.\n* Individuals with a history of Tdap vaccination prior to administration of the investigational product.\n* Pregnant and breastfeeding women.\n* Individuals who have participated in other clinical trials involving investigational products\u002Fdevices within 6 months prior to administration of the investigational product.","19 Years","64 Years",{"count":102,"type":22},120,[54,55],"This clinical trial consists of two parts: Part 1, which explores safety, and Part 2, which examines both safety and efficacy (immunogenicity). Part 1 is a single-center, open-label, single-group study, while Part 2 is designed as a multicenter, double-blind, randomized, active-controlled trial.",[106],"Tetanus-diphtheria-acellular Pertussis (Tdap)","2025-07-08",{"date":109,"type":34},"2025-07-10",{"date":111,"type":34},"2025-06-05",{"date":113,"type":22},"2026-05",{"name":40,"class":41},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":100,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},"100492024","phase-3-a-study-to-investigate-the-safety-and-efficacy-of-undiluted-intravenous-infusion-of-iv-hepabig-inj-100492024","NCT05686759","A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.","A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients","Inclusion Criteria:\n\n1. Aged ≥18 and \\\u003C65 years at the time of signing the consent form\n2. Subjects who had history of liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure and received treatment for prevent hepatitis B recurrence\n3. HBsAg(+) before liver transplantation\n4. Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit\u002F4weeks regimen\n\nExclusion Criteria:\n\n1. Subject with history of anaphylaxis to any component of the investigational product\n2. Pregnant or breast-feeding women\n3. Deficiency of Immunoglobulin A\n4. Clinically significant renal diseases (serum creatinine \\>2.0mg\u002FdL, anuria, renal failure or on dialysis at screening)\n5. Hemophilia\n6. Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus\n7. Subject with history of malignancy within the last 5 years (excluding primary liver cancer)\n8. Subject received estrogen or hormone replacement therapy within 3 months before screening\n9. HBsAg or HBeAg or HBV DNA positive at screening\n10. Anti HBs titer less than below criteria at screening \\\u003C150 IU\u002FL for subject whose HBeAg and HBV DNA were negative(-) before liver transplantation \\>500 IU\u002FL for subject whose HBeAg or HBV DNA were positive(+) before liver transplantation\n11. Subject with history of drug abuse\n12. Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening\n13. Subject who are determined disqualified to join clinical trials by investigator",{"count":123,"type":22},105,[25],"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",[127],"Hepatitis B",[127,129,130,131],"Liver Transplantation","Hepatitis B Immunoglobulin","Liver Diseases","2025-06-18",{"date":134,"type":34},"2025-06-25",{"date":136,"type":34},"2023-04-13",{"date":138,"type":22},"2026-06-30",{"name":40,"class":41},8,""]