[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495442":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":38,"collaborators":20,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":20,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":20,"enrollmentInfo":49,"targetDuration":20,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ropeginterferon alfa-2b","EXPERIMENTAL","Eligible subjects will receive ropeg subcutaneously (SC) every 2 weeks at the starting dose of 250µg at week 0, 350 µg at week 2, then 500µg at a fixed dose from week 4 onwards until week 104. In patients achieving a clinical or molecular response at 24 months (week 104), treatment with ropeg will be continued until disease progression.\n\nIntervention: Drug: Ropeginterferon alfa-2b",[13],"Drug: Ropeginterferon Alfa-2B Prefilled Syringe [Besremi]",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Ropeginterferon Alfa-2B Prefilled Syringe [Besremi]","Eligible subjects will receive Ropeginterferon alfa-2b subcutaneously (SC) every 2 weeks at the starting dose of 250µg at week 0, 350 µg at week 2, then 500µg at a fixed dose from week 4 onwards",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Gill Harinder","CONTACT","+852 22554542","gillhsh@hku.hk",[28],{"facility":5,"status":29,"city":30,"state":20,"zip":20,"country":31,"countryCode":32,"cosmosGeoPoint":20,"geoPoint":20,"contacts":33},"RECRUITING","Taipei, Taiwan, 100","Taiwan","TW",[34],{"name":35,"role":24,"phone":36,"phoneExt":20,"email":37},"hsinan hou","0972653089","hsinanhou@ntu.edu.tw",{"type":39,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100495442","phase-2-ropeginterferon-alfa-2b-for-early-myelofibrosisdipss-lowintermediate-1-risk-myelofibrosis-100495442",false,"NCT05731245","Ropeginterferon Alfa 2b for Early MyelofibrosisDIPSS Low\u002FIntermediate-1 Risk Myelofibrosis","Efficacy and Safety of Ropeginterferon Alfa-2b for Pre-fibrotic Primary Myelofibrosis and DIPSS Low\u002FIntermediate-1 Risk Myelofibrosis","Inclusion Criteria:\n\n* Adults ≥ 18 years (or based on the legal age of the territory) Diagnosed of primary myelofibrosis, post-PV and post-ET myelofibrosis according to the WHO 2016 classification Bone marrow reticulin fibrosis grade of 0-1 or low\u002Fintermediate-1 risk according to DIPSS Compensated liver function defined as: bilirubin ≤ 1.5 x upper limit normal (ULN); alanine aminotransferase (ALT) ≤ 2 x ULNor aspartate aminotransferase (AST) ≤ 2 x ULN; prothrombin time versus control \\\u003C3 seconds at screening Glomerular filtration rate ≥ 50 mL\u002Fmin (by MDRD equation or Cockcroft-Gault formula) Men and women of childbearing potential must agree to perform contraception until 28 days after the last dose of ropeg.\n\nWomen must avoid breast-feeding during the study. Able to give a written informed consent and fully comply to the requirements of the study.\n\nExclusion Criteria:\n\n* Prior or current use of IFNα preparations for PMF or secondary MF. Prior use of IFNα for antecedent PV or ET is allowed provided that the time from the last dose of IFNα to recruitment is \\> 4 weeks.\n\nPatients currently on other investigational therapy (ies) Contraindications or hypersensitivity to IFNα preparations History of organ transplantation Pregnant or lactating women Documented autoimmune disease at screening Infection with human immunodeficiency virus (HIV) Active and uncontrolled infections with hepatitis B virus (HBV) and hepatitis C virus (HCV). Please note that patients on antiviral therapy with undetectable HBV DNA and HCV RNA may be recruited.\n\nEvidence of severe retinopathy including but not limited to macular degeneration, diabetic retinopathy and hypertensive retinopathy.\n\nHistory of clinically significant neuropsychiatric conditions including but not limited to depression and epilepsy.\n\nClinically significant neuropsychiatric conditions including but not limited to depression and epilepsy.\n\nPresence of other active malignancies within three years prior to the time of recruitment. History of malignant disease, including solid tumours and haematological 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.\n\nEvidence of alcohol or drug abuse within 6 months","ALL","20 Years",{"count":50,"type":51},50,"ESTIMATED","INTERVENTIONAL",[54],"PHASE2","This is a multi-centre phase 2 open-label prospective study designed to assess the efficacy and safety of ropeg patients with pre-fibrotic primary myelofibrosis or DIPSS low\u002Fintermediate-1 risk myelofibrosis after 24 months of treatment.",[57],"Pre-fibrotic Myelofibrosis",[59],"Early or Primary Myelofibrosis","2023-02-07",{"date":62,"type":63},"2023-02-16","ACTUAL",{"date":65,"type":63},"2023-02-08",{"date":67,"type":51},"2026-10-12",{"name":5,"class":6},1]