[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644722":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":47,"responsibleParty":65,"collaborators":12,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":12,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":12,"maxAge":12,"enrollmentInfo":75,"targetDuration":12,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":12,"overallStatus":49,"whyStopped":12,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Riphah International University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Blood transfusion Group","NO_INTERVENTION","Control group will be on regular blood transfusion and iron chelation therapy",null,{"label":14,"type":15,"description":16,"interventionNames":17},"HbF inducers","EXPERIMENTAL","All patients will receive thalidomide and hydroxyurea. Low dose Thalidomide will be administered to patients at a low dose of 0.5 to 4 mg\u002Fkg orally every day for 12 months until continuous transfusion-dependency or unacceptable toxicity occurred. The starting dose of hydroxyurea will be 10-20 mg\u002Fkg per day.",[18,19],"Drug: Thalidomide","Drug: Hydroxy Urea",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Thalidomide","Tab Thalidomide 0.5 to 4 mg\u002Fkg orally every day for 12 months",[14],[27],"Thalido",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Hydroxy Urea","Tab Hydroxyurea 10-20 mg\u002Fkg per day for 12 months",[14],[33],"Hydrea",[35],{"name":36,"affiliation":37,"role":38},"Fariha Sardar, MBBS, FCPS","Riphah International University, Rwp","PRINCIPAL_INVESTIGATOR",[40,44],{"name":36,"role":41,"phone":42,"phoneExt":12,"email":43},"CONTACT","+923335517877","doc.fariha@yahoo.com",{"name":36,"role":41,"phone":45,"phoneExt":12,"email":46},"+923350941494","afzaal2kmt20@gamil.com",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":12,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Rawalpindi","Punjab Province","Pakistan","PK",{"type":55,"coordinates":56},"Point",[57,58],73.0479,33.59733,{"lat":58,"lon":57},[61,63],{"name":62,"role":41,"phone":42,"phoneExt":12,"email":43},"Fariha Sadar, MBBS, FCPS",{"name":64,"role":41,"phone":45,"phoneExt":12,"email":46},"Fariha Saradr, MBBS, FCPS",{"type":66,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100644722","safety-and-efficacy-of-hemoglobin-f-inducers-in-patients-with-beta-thalassemia-100644722",false,"NCT07673302","Safety and Efficacy of Hemoglobin F Inducers in Patients With Beta Thalassemia","Safety and Efficacy of Hemoglobin F Inducers in Patients With Beta Thalassemia: a Prospective 12 Months Study","Inclusion criteria:\n\n* Confirmed diagnosis of Beta thalassemia Major (BTM) ascertained by Hemoglobin Electrophoresis or HPLC report performed pre-transfusion or genetic testing profile (comprising PCR or HBB gene sequencing) suggestive of β-thalassemia syndrome.\n* All ages and both genders will be included\n* Written informed consent\n\nExclusion criteria:\n\n* Pregnancy or unwilling to follow contraception or planning conception (Enrolled female patients will be strictly advised to avoid pregnancy during the study period and until 6 months after thalidomide withdrawal.\n* Hemoglobinopathies other than beta thalassemia\n* History of neurological problems\n* Inability to regularly follow up","ALL",{"count":76,"type":77},240,"ESTIMATED","INTERVENTIONAL",[80],"NA","The aim of this study is to determine the safety and therapeutic effect of HbF inducers (combination therapy: thalidomide and hydroxyurea) on beta thalassemia patients. The main objectives of this study are:\n\n* To determine the therapeutic efficacy of HbF inducers (combination therapy: thalidomide and hydroxyurea) on hemoglobin level and blood transfusion in beta thalassemia patients.\n* To determine the safety of HbF inducers (combination therapy: thalidomide and hydroxyurea) in beta thalassemia patients\n* To determine effect of HbF inducers (combination therapy: thalidomide and hydroxyurea) on quality of life of beta thalassemia patients",[83],"Thalassemia","2026-08-04",{"date":86,"type":87},"2026-08-06","ACTUAL",{"date":89,"type":87},"2026-06-20",{"date":91,"type":77},"2027-06-19",{"name":5,"class":6},1]