[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585610":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":35,"locations":45,"responsibleParty":64,"collaborators":68,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":26,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":26,"enrollmentInfo":95,"targetDuration":26,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Hospital Universitario Dr. Jose E. Gonzalez","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Study group","ACTIVE_COMPARATOR","Oral prednisone 1 mg\u002Fkg\u002Fday for 14 days or IV dexamethasone 0.15 mg\u002Fkg\u002Fday for 14 days + human chorionic gonadotropin 2500 IU intramuscular on days 1, 3, and 5 of the protocol. Patients who have at least a partial response by day 7 will receive 3 weekly doses for an additional 4 weeks.",[13,14,15],"Drug: Human chorionic gonadotropin (hCG)","Drug: Prednisone","Drug: Dexamethasone",{"label":17,"type":10,"description":18,"interventionNames":19},"Control group","Oral prednisone 1 mg\u002Fkg\u002Fday for 14 days or IV dexamethasone 0.15 mg\u002Fkg\u002Fday for 14 days.",[14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Human chorionic gonadotropin (hCG)","2500 IU intramuscular on days 1, 3, and 5 of the protocol. Patients who have at least a partial response by day 7 will receive 3 weekly doses for an additional 4 weeks.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Prednisone","Oral prednisone 1 mg\u002Fkg\u002Fday for 14 days",[17,9],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Dexamethasone","IV dexamethasone 0.15 mg\u002Fkg\u002Fday for 14 days",[17,9],[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Cesar H Gutierrez Aguirre, MD","CONTACT","+52 (81) 83891194","hematohu@yahoo.com",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"David Gómez Almaguer, MD","+52‭(81) 8348 8510‬","dgomezalmaguer@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Universidad Autónoma de Nuevo León","RECRUITING","Monterrey","Nuevo León","64460","Mexico","MX",{"type":55,"coordinates":56},"Point",[57,58],-100.31721,25.68435,{"lat":58,"lon":57},[61],{"name":62,"role":38,"phone":63,"phoneExt":26,"email":40},"Cesar H Gutiérrez Aguirre, MD","+ (52) 8183891194",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Cesar Homero Gutierrez-Aguirre","Principal Investigator",[69,72,74,76,78,80,82,84],{"name":70,"class":71},"Marisa Romero Martínez","UNKNOWN",{"name":73,"class":71},"Dr. José Carlos Jaime Perez",{"name":75,"class":71},"Dr. David Gómez Almaguer",{"name":77,"class":71},"Dra. Consuelo Mancias Guerra",{"name":79,"class":71},"Dr. Andrés Gómez de León",{"name":81,"class":71},"Dra. Olga Graciela Catú Rodríguez",{"name":83,"class":71},"Dra. Perla Colunga Pedraza",{"name":85,"class":71},"Dra. Michelle Morcos Sandino","100585610","phase-2-efficacy-of-human-chorionic-gonadotropin-in-acute-gvhd-treatment-100585610",false,"NCT06904599","Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment","Evaluation of Human Chorionic Gonadotropin for the Treatment of Acute Graft-versus-host Disease in Patients With Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Any gender.\n* Post-allogeneic transplantation status (haploidentical or identical) of hematopoietic cells.\n* Presenting recently onset aGVHD, grades 2 to 4, and requiring systemic steroid use as determined by the treating physician.\n* Have not received steroids (Prednisone ≥1 mg\u002Fkg\u002Fday or equivalent dose of another steroid) for more than 3 days in the last week.\n* Willing to participate in the study by signing informed consent.\n* If the subject is female and has the potential to procreate (a woman is considered fertile from menarche to postmenopausal stage or after undergoing a permanent contraceptive method), she agrees to use one of the following contraceptive methods from the start of the study and for 30 days after the protocol: oral hormonal contraception, intrauterine device, barrier methods (diaphragm, male or female condom, and foam, sponge, or spermicide film), or agrees to remain abstinent. Women who have been postmenopausal for more than a year, undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy are not considered to have reproductive potential.\n* If the subject is male, he agrees to use one of the following contraceptive methods from the start of the study and for 30 days after the protocol: male condom, or remain abstinent.\n\nExclusion Criteria:\n\n* Arterial or venous thrombosis in the past 3 months.\n* History of thromboembolic disease requiring full-dose anticoagulation.\n* Diagnosis of active malignant disease.\n* Uncontrolled infection.\n* Chronic use of supplemental therapy with sex hormones (estrogen, progesterone, and\u002For testosterone).\n* Women with a positive pregnancy test at the time of the initial evaluation.\n* Women or men of reproductive age who are unwilling to take appropriate precautions to avoid an unwanted pregnancy from the start of the protocol until 30 days after the protocol.","ALL","18 Years",{"count":96,"type":97},20,"ESTIMATED","INTERVENTIONAL",[100],"PHASE2","Graft-versus-host disease is a complication of allogeneic hematopoietic cell transplantation with high morbidity and mortality. The standard treatment is corticosteroids, and based on the response within 3 to 7 days, a second-line therapy is added, which is expensive and not easily accessible. The administration of human chorionic gonadotropin has shown therapeutic effectiveness in 50% of patients in reported clinical cases.",[103],"Acute Graft Versus Host Disease",[105,106],"Acute GVHD","human chorionic gonadotropin","2025-03-31",{"date":109,"type":110},"2025-04-03","ACTUAL",{"date":112,"type":110},"2025-02-01",{"date":114,"type":97},"2026-01-31",{"name":5,"class":6},1]