[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644722":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":47,"responsibleParty":64,"collaborators":12,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":12,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":12,"maxAge":12,"enrollmentInfo":74,"targetDuration":12,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":12,"overallStatus":83,"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":12,"city":49,"state":50,"zip":12,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Rawalpindi","Punjab Province","Pakistan","PK",{"type":54,"coordinates":55},"Point",[56,57],73.0479,33.59733,{"lat":57,"lon":56},[60,62],{"name":61,"role":41,"phone":42,"phoneExt":12,"email":43},"Fariha Sadar, MBBS, FCPS",{"name":63,"role":41,"phone":45,"phoneExt":12,"email":46},"Fariha Saradr, MBBS, FCPS",{"type":65,"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":75,"type":76},240,"ESTIMATED","INTERVENTIONAL",[79],"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",[82],"Thalassemia","NOT_YET_RECRUITING","2026-06-23",{"date":86,"type":87},"2026-06-29","ACTUAL",{"date":89,"type":76},"2026-06-20",{"date":91,"type":76},"2027-06-19",{"name":5,"class":6},1]