[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561807":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":44,"collaborators":24,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":24,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":24,"enrollmentInfo":55,"targetDuration":24,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":71,"whyStopped":24,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Hansoh BioMedical R&D Company","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HS-20106 Cohort 1","EXPERIMENTAL","Part A: Non-transfusion dependent population",[13],"Drug: HS-20106",{"label":15,"type":10,"description":16,"interventionNames":17},"HS-20106 Cohort 2","Part A: Transfusion-Dependent Population（low-transfusion burden (LTB) and high-transfusion burden (HTB)）",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","HS-20106","HS-20106 administered subcutaneously every 4 weeks for up to 6 cycles. Eligible participants may be able to continue to receive subcutaneously administered HS-20106 after completing 6 cycles in the extended treatment period.",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Zhijian Xiao, PhD","CONTACT","(0086)022-23909184","xiaozj_mds026@163.com",[32],{"facility":33,"status":24,"city":34,"state":35,"zip":24,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":24},"Institute of Hematology and Blood Diseases Hospital","Tianjin","Tianjin Municipality","China","CN",{"type":39,"coordinates":40},"Point",[41,42],117.17667,39.14222,{"lat":42,"lon":41},{"type":45,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100561807","phase-2-a-study-of-hs-20106-to-treat-anemia-due-to-very-low-low-or-intermediate-risk-myelodysplastic-syndromes-100561807",false,"NCT06594965","A Study of HS-20106 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes","Phase II Study on the Efficacy, Safety, and Pharmacokinetics of HS-20106 in Patients With IPSS-R Very Low-risk, Low-risk, or Moderate-risk Myelodysplastic Syndrome (MDS) Anemia","Inclusion Criteria:\n\n1. Diagnosis of MDS according to World Health Organization (WHO) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease（IPSS-R ≤ 3.5）.\n2. \\\u003C 5% blasts in bone marrow and \\\u003C 1% blasts in peripheral blood.\n3. Each cohort is defined as:\n\n   Cohort 1： In NTD participants, having received no red blood cell (RBC) transfusions within 16 weeks Hgb concentration between 60 and 100g\u002FL.\n\n   Cohort 2： In LTB participants, having received an average of \\\u003C 4 units of RBC transfused within 8 weeks (i.e., total blood transfused over 16 weeks\u002F2) Hgb concentration between 60 and 100 g\u002FL.\n\n   In HTB participants, having received an average of ≥ 4 units of RBC transfused within 8 weeks (i.e., total blood transfused over 16 weeks\u002F2) Hgb concentration between 60 and 100 g\u002FL.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia.\n5. Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.\n\nExclusion Criteria:\n\n1. Chromosome 5q deletion, del (5q).\n2. Anemia caused by other reasons, such as iron deficiency anemia, megaloblastic anemia, aplastic anemia, renal anemia or blood loss.\n3. Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and\u002For radiation for other diseases).\n4. Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.\n5. Treatment within 4 weeks prior to C1D1 with:\n\n1\\) Erythropoiesis stimulating agent (ESA) OR 2) Granulocyte colony-stimulating factor (G-CSF) OR 3) Granulocyte-macrophage colony-stimulating factor (GM-CSF) 6. Iron chelation therapy if initiated within 8 weeks prior to C1D1. 7. Vitamin B12 therapy if initiated within 8 weeks prior to C1D1. 8. Treatment with another investigational drug or device or approved therapy for investigational use \\\u003C or = 4 weeks prior to C1D1, or if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer.\n\n9\\. Peripheral blood white blood cell count \\>13.0 x 10\\*9\u002FL. 10. Neutrophil count \\\u003C 1.0 x 10\\*9\u002FL. 11. Platelet count \\> 450 x 10\\*9\u002FL or \\\u003C 30 x 10\\*9\u002FL. 12. Transferrin saturation \\\u003C 15%. 13. Ferritin \\\u003C 15 μg\u002FL. 14. Folate \\\u003C 4.5 nmol\u002FL (\\\u003C 2.0 ng\u002FmL). 15. Vitamin B12 \\\u003C 148 pmol\u002FL (\\\u003C 200 pg\u002FmL). 16. Estimated glomerular filtration rate (GFR) \\\u003C 40 mL\u002Fmin\u002F1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\].\n\n17\\. Pregnant or lactating females","ALL","18 Years",{"count":56,"type":57},176,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of HS-20106 on anemia in patients with very low, low or intermediate risk MDS.",[63,64,65,66],"Myelodysplastic Syndromes","Anemia","MDS","Bone Marrow Disease",[65,21,68,69,70],"KER-050","fusion protein","TGF-β","NOT_YET_RECRUITING","2024-09-14",{"date":74,"type":75},"2024-09-19","ACTUAL",{"date":77,"type":57},"2024-10-30",{"date":79,"type":57},"2026-10-30",{"name":5,"class":6},1]