[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PharmaEssentia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,76],{"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":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":48},"100552049","phase-3-p1101-in-treating-patients-with-early-pmf-or-overt-pmf-at-low-or-intermediate-1-risk-100552049",false,"NCT06468033","P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk","A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b (P1101) in Adult Patients With Pre-fibrotic\u002FEarly Primary Myelofibrosis (PMF) or Overt PMF at Low or Intermediate-1 Risk According to DIPSS Plus (HOPE-PMF): The Core Study and Its Extension Study","Inclusion Criteria:\n\n1. Male or female patients aged ≥18 years at the time of signing the informed consent form;\n2. Patients with pre-fibrotic\u002Fearly PMF (Pre-PMF) or overt primary myelofibrosis at low to intermediate-1 risk according to DIPSS plus, diagnosed according to WHO 2016 or 2022 classification;\n3. With good liver function at screening, which is defined as total bilirubin ≤1.5 × upper limit of normal (ULN), international normalized ratio (INR) ≤1.5 × ULN, albumin \\>3.5 g\u002FdL, alanine aminotransferase (ALT) ≤2.0 × ULN, and aspartate aminotransferase (AST) ≤2.0 × ULN;\n4. Hgb ≥10.0 g\u002FdL at screening;\n5. Neutrophil count ≥1.0 × 10\\^9\u002FL at screening;\n6. Creatinine clearance rate ≥30 mL\u002Fmin at screening (according to the Cockcroft-Gault formula);\n7. Females of childbearing potential, as well as all women \\<2 years after the onset of menopause, must agree to use an acceptable form of birth control until 60 days following the last dose of the study drug, and females must agree to not breastfeed during the study;\n8. Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Any known contraindications to interferon α or hypersensitivity to interferon α;\n2. Patients with prior interferon therapy having poor tolerability or lack of efficacy to the previous interferon therapy per investigator\\'s judgement;\n3. Patients with an ongoing cytoreduction (e.g., HU or IFN-α) at the time of screening if, in the Investigator's opinion, randomizing them into the placebo arm will lead to immediate rebound increase of peripheral blood counts and thus may jeopardize their health status;\n4. With severe or serious diseases that, in the Investigator's opinion, may affect the patient's participation in this study;\n5. History of major organ transplantation;\n6. Pregnant or breastfeeding women;\n7. Patients with any other diseases that will affect the study results or may weaken the compliance to protocol per the Investigator's judgment;\n8. Use any investigational drug \\<4 weeks prior to the first dose of study drug, or not recovered from effects of prior administration of any investigational drug.\n9. Eligible for JAK inhibitor therapy at screening.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a phase 3 double-blind clinical trial arm to test Ropeginterferon alfa-2b (P1101) in adult patients with Primary Myelofibrosis (PMF) at early stage or low to medium risk.\n\nParticipants will receive the study drug\u002Fplacebo bi-weekly and have an assessment visit every 4 weeks. The ratio of study drug to placebo group is 2:1.",[26,27],"Primary Myelofibrosis","Myeloproliferative Neoplasm",[29,26,30,31,32,33,34,35,36],"P1101","PMF","Ropeginterferon","PharmaEssentia","Myeloproliferative neoplasms","MPN","Pre-fibrotic","Low or Intermediate-1 Risk","RECRUITING","2025-08-08",{"date":40,"type":41},"2025-08-13","ACTUAL",{"date":43,"type":41},"2025-07-18",{"date":45,"type":20},"2028-09-30",{"name":32,"class":47},"INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100567252","hla-a0201-allele-frequency-and-the-ny-eso-1-expression-status-in-cancer-patients-in-taiwan-100567252","NCT06665776","HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan","A Prospective Observational Human Subject Research to Explore the HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign an informed consent form (ICF).\n2. Adult aged ≥ 18 years at the time of informed consent (or other age required by local regulations).\n3. Confirmed diagnosis of any of the following solid tumor:\n\n   1. Head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma;\n   2. Hepatocellular carcinoma;\n   3. Lung squamous cell carcinoma;\n   4. Synovial sarcoma;\n   5. Triple-negative breast cancer;\n   6. Esophageal squamous cell carcinoma;\n   7. Cervical cancer;\n   8. Ovarian cancer\n4. Patient who received standard curative or palliative therapy including but not limited to any targeted therapy based on mutation status for their cancer, or patient with advanced solid tumors for which there is no accepted therapy, standard therapies are no longer effective, or the patient refuses additional standard therapy.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.\n6. Body weight ≥ 50 Kg.\n7. Life expectancy of ≥ 6 months.\n8. Patient who agrees to provide the tumor sample for NY-ESO-1 IHC staining, from either fresh or archival tissue\n\nExclusion Criteria:\n\n1. Known primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or AIDS).\n2. Uncontrolled intercurrent illness which is not suitable for enrollment at the discretion of the investigator, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements.\n3. Currently confirmed diagnosis of at least 2 active cancers; patient who was cured of the other cancer \\[disease free period \\> 6 months\\] and currently has only one research targeted tumor can be enrolled.\n4. Untreated or symptomatic brain metastasis.\n5. History of organ transplantation or allogeneic stem cell transplantation.\n6. Other conditions (e.g. previous use of any cell therapy) which are not suitable for enrollment at the discretion of the investigator.",{"count":57,"type":20},1200,"1 Day","OBSERVATIONAL","This is a prospective observational research to explore the frequency of Human leukocyte antigen A allele 02:01 (HLA\\*02:01) and the expression status of New York esophageal squamous cell carcinoma-1 (NY-ESO-1) in cancer patients in Taiwanese population.",[62],"Solid Tumor Malignancy",[64,65,66],"NY-ESO-1","HLA-A*02:01","Solid tumor","2025-07-28",{"date":69,"type":41},"2025-07-30",{"date":71,"type":41},"2023-03-14",{"date":73,"type":20},"2025-12-31",{"name":32,"class":47},6,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100538433","phase-4-efficacy-and-safety-of-ropeginterferon-alfa-2b-p1101-for-patients-with-polycythemia-vera-100538433","NCT06290765","Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera","Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera - A Randomized Open Label Global Multicenter Study (PARADIGM-PV)","PV","Inclusion Criteria:\n\n1. Age ≥18 years at the time of informed consent (or other age required by local regulations);\n2. PV according to the World Health Organization (WHO) 2016 or 2022 Criteria;\n3. At least 3 phlebotomies within 24 weeks or at least 5 phlebotomies within 52 weeks prior to screening due to inadequate control of Hct value;\n4. Have the following hematological values immediately prior to randomization at baseline:\n\n   1. Hematocrit \\\u003C45%, and\n   2. WBC ≥4× 109\u002FL, and\n   3. Platelets ≥100 × 109\u002FL;\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.\n6. Patients receiving cytoreductive therapy must be on a stable dose or minimal dose adjustments for at least 24 weeks before screening and with no planned dose change;\n7. Patients who are not receiving cytoreductive therapy must have been discontinued from any prior cytoreductive therapy for at least 24 weeks before screening and have recovered from any adverse events;\n8. Females of childbearing potential, as well as all women \\\u003C 2 years after the onset of menopause, must agree to use an acceptable form of birth control until 60 days following the last dose of the study drug;\n9. Written informed consent obtained from the patient or the patient's legal representative, and ability for the patient to comply with the study requirements.\n\nExclusion Criteria:\n\n1. Patients requiring phlebotomy at Hct levels ˂45% according to Investigator judgement;\n2. Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) or PV-related bleeding within 2 months prior to randomization;\n3. Post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) (Tefferi et al 2013, Barosi et al 2008);\n4. Contraindication to pegylated interferon or its excipients;\n5. known resistance or intolerance to interferon based therapies, as judged by Investigator;\n6. Documented autoimmune disease (e.g., thyroid dysfunction, idiopathic thrombocytopenic purpura (ITP), scleroderma, psoriasis, or any arthritis of autoimmune origin). Patients with well-managed thyroid disease by oral hormonal replacement therapy could be enrolled;\n7. Pulmonary infiltrates, pneumonia, and pneumonitis at screening that, in the Investigator's opinion, would jeopardize the safety or compliance with the protocol;\n8. Infections with systemic manifestations, e.g., bacterial, fungal, or human immunodeficiency virus (HIV), except inactive carriers of hepatitis B (HBV) and\u002For hepatitis C (HCV) at screening; inactive HBV carrier is defined as the presence of HBsAg and anti-Hepatitis B e-antigen (anti-HBe) antibody, HBV DNA ˂2000 IU\u002Fml, and normal ALT (Invernizz et al 2016); inactive HCV carrier is defined as the presence of HCV RNA but has normal ALT or with no clinically significant symptom as judged by investigator;\n9. Any investigational drug less than 6 weeks prior to randomization or not recovered from the effects of prior administration of any investigational agent;\n10. History or presence of depression requiring treatment with antidepressant;\n11. Previous suicide attempts or at any risk of suicide at screening, in the judgement of the Investigator;\n12. Any significant morbidity or abnormality which may interfere with the study participation;\n13. Pregnant or lactating females;\n14. History of alcohol abuse or drug abuse within the last year;\n15. Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension);\n16. Significant liver (AST or ALT \\> 2.5 times ULN) or renal disease (creatinine \\> 2 mg\u002Fml);\n17. History of major organ transplantation;\n18. History or presence of clinically significant neurologic diseases, e.g., uncontrolled severe seizure disorder;\n19. History of malignant disease, including solid tumors and hematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that have been completely excised and are considered cured) within the last 3 years.","59 Years",{"count":86,"type":20},70,[88],"PHASE4","This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with PV. The entire study period is 60 weeks, including a main treatment phase (32 weeks), an extension treatment phase (24 weeks), and a safety follow-up phase (four weeks). However, the study may be extended for additional period of treatment after Week 60 pending the primary endpoint analysis at Week 32. Approximately 70 patients with PV will be enrolled.",[91,27],"Polycythemia Vera",[82,93,94,29,95,96,97],"MPNs","Ropeginterferon alfa-2b","Hct","Phlebotomy","JAK2","NOT_YET_RECRUITING",{"date":100,"type":41},"2025-07-31",{"date":102,"type":20},"2026-02-01",{"date":104,"type":20},"2027-06-30",{"name":32,"class":47},""]