[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590070":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":31,"locations":40,"responsibleParty":79,"collaborators":81,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":35,"enrollmentInfo":94,"targetDuration":35,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":66,"whyStopped":35,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention arm","EXPERIMENTAL","Intervention arm will receive a human normal immunoglobulin to be administered intravenously, once daily for 2 consecutive days (Day 1 and Day 2).\n\nIf the platelet count is not maintained for the desired duration after the first immunoglobin infusion, and at the discretion of the investigator and the patient\u002Flegal representative, participants may receive up to one additional cycle between Day 15 and Day 30 Pre-Medication Rapid IV infusion of 500 mL of 0.9% saline, 50 mg of diphenhydramine IV followed by saline 0.9% slow infusion Pediatrics, before the infusion of PSI, an IV infusion of 0.9% sodium chloride (normal saline) at 10 mL\u002Fkg over 1 hour, up to a maximum volume of 500 mL, will be administered, along with diphenhydramine 1.25 mg\u002Fkg IV, up to a maximum dose of 50 mg.\n\nAt the end of the V IMMUNE® infusion, administer 0.9% sodium chloride IV at 10 mL\u002Fkg, up to a maximum of 500 mL, at an infusion rate of 10 mL\u002Fkg, to maintain a patent venous access for at least 30 to 40 minutes.",[13],"Biological: 5% (5g\u002F100 ml) intravenous immunoglobin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","5% (5g\u002F100 ml) intravenous immunoglobin","A 5% human normal immunoglobulin I.P. (5 g\u002F100 mL) V-IMMUNE® will be administered at a dose of 1 g\u002Fkg, intravenously, once daily for 2 consecutive days (Day 1 and Day 2). The infusion rate starts at 0.01 mL\u002Fkg\u002Fmin during the first 30 minutes and is gradually increased up to 0.06 mL\u002Fkg\u002Fmin if no adverse events occur. This will constitute the first cycle of V-IMMUNE® treatment. The dose of 1 g\u002Fkg\u002Fday on 2 consecutive days is consistent with recommendations for the use of other IVIG products in Immune Thrombocytopenia.\n\nIf the platelet count is not maintained for the desired duration after the first V-IMMUNE® cycle, and at the discretion of the investigator and the patient\u002Flegal representative, participants may receive up to one additional cycle of V-IMMUNE®-at the same dosing regimen used in Cycle 1-between Day 15 and Day 30\n\nPre-medication before infusion :\n\nIV rapidly infusion of 0.9% normal saline 500 mL, or 10 ml\u002Fkg pediatrics and diphenhydramine 50 mg IV or 1.25 mg\u002Fkg IV (pediatrics)",[9],[21],"V-IMMUNE",[23,27],{"name":24,"affiliation":25,"role":26},"Sandra Regina Loggetto, PhD","HCor Research Institute","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":29,"role":30},"Israel Silva Maia, PhD","HCor research institute","STUDY_DIRECTOR",[32,37],{"name":28,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","+55-48-9-8413-1510",null,"ismaia@hcor.com.br",{"name":24,"role":33,"phone":38,"phoneExt":35,"email":39},"+55-11-9-7622-5837","loggetto.sr@hotmail.com",[41,64],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"IMIP Instituto de Medicina Integral Professor Fernando Figueira","NOT_YET_RECRUITING","Recife","Pernambuco","50070-902","Brazil","BR",{"type":50,"coordinates":51},"Point",[52,53],-34.88111,-8.05389,{"lat":53,"lon":52},[56,60,63],{"name":57,"role":33,"phone":58,"phoneExt":35,"email":59},"Liana Ariel Siqueira Lira, MD","55- 81- 2122-4100","lianaarielslira@gmail.com",{"name":61,"role":33,"phone":35,"phoneExt":35,"email":62},"Danielle Menor","danielle.menor@imip.org.br",{"name":57,"role":26,"phone":35,"phoneExt":35,"email":35},{"facility":65,"status":66,"city":67,"state":67,"zip":68,"country":47,"countryCode":48,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Santa Casa de Misericórida de São Paulo","RECRUITING","São Paulo","01221020",{"type":50,"coordinates":70},[71,72],-46.63611,-23.5475,{"lat":72,"lon":71},[75],{"name":76,"role":33,"phone":77,"phoneExt":35,"email":78},"Ana Clara Kneese, PhD","+5511988206769","ackneese@terra.com.br",{"type":80,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[82],{"name":83,"class":6},"Hospital do Coracao","100590070","phase-3-v-immune-for-immune-thrombocytopenia-100590070",false,"NCT06962631","V-IMMUNE® for Immune Thrombocytopenia","V-IMMUNE® for Immune Thrombocytopenia: A Prospective Multicenter Study to Evaluate the Efficacy and Safety of Human Immunoglobulin in Adult and Pediatric Participants With Immune Thrombocytopenia. TIP Study","TIP","Inclusion Criteria:\n\n* Age ≥1 year;\n* Confirmed diagnosis of immune thrombocytopenia ( newly diagnosed, persistent or chronic);\n* Platelet count ≤20,000\u002Fmm³ at the time of enrollment;\n* No other conditions that, in the investigator's opinion, could cause thrombocytopenia;\n* Agreement to use effective contraceptive practices\u002Fmethods throughout the entire study participation by female patients of childbearing potential and able to become pregnant, unless there is a documented medical contraindication.\n\nExclusion Criteria:\n\n* Non-immune thrombocytopenia\n* Active sepsis\n* Pregnancy (pregnant or breastfeeding)\n* History of hypersensitivity reaction to blood or blood products, IVIG, or any other IgG preparation\n* Intolerance to any component of V-IMMUNE®\n* Previous diagnosis of IgA deficiency, history of reactions to products containing IgA, or history of anti-IgA antibodies\n* Participation in any other study involving an investigational product\n* Known HIV, HCV, or HBV infection\n* AST (TGO) and\u002For ALT (TGP) \\>2.5× the upper limit of normal or 2.5 times baseline values\n* Serum creatinine \\>2× the upper limit of normal or 2 times baseline values\n* BUN \\>2.5× the upper limit of normal or 2.5 times baseline values\n* History of NYHA class III or IV heart failure\n* Uncontrolled hypertension with systolic BP \\>180 mmHg or diastolic BP \\>100 mmHg\n* A history of hyperviscosity states, transient ischemic attack (TIA), stroke, other thromboembolic events, or acute coronary syndrome (ACS)\n* Neoplasia under active treatment\n* Child-Pugh class B or C liver failure\n* Alcohol, opioid, or psychotropic substance abuse within the past 12 months\n* Receipt of rituximab within 6 months prior to Day 1\n* Acute or chronic conditions (e.g., but not limited to, renal disease or diseases predisposing to renal impairment, coronary artery disease, or protein-losing enteropathy) that, in the investigator's opinion, may interfere with the conduct of the study\n\nAn acquired health condition such as chronic lymphocytic leukemia, multiple myeloma, or chronic or recurrent neutropenia (absolute neutrophil count \\\u003C1,000\u002Fmm³)\n\nHistory of hemolytic anemia\n\nReceipt of any IV immunoglobin preparation within 1 month prior to Day 1\n\nUse of corticosteroids, cyclophosphamide, azathioprine, or attenuated androgens with a planned dose increase before Day 10 following IV immunoglobin infusion","ALL","1 Year",{"count":95,"type":96},31,"ESTIMATED","INTERVENTIONAL",[99],"PHASE3","This is a multicenter, prospective clinical trial evaluating the efficacy and safety of V-IMMUNE®, a 5% human normal immunoglobulin formulation administered intravenously, for the treatment of immune thrombocytopenia (ITP) in patients aged ≥1 year. The primary objective is to assess the proportion of patients achieving a platelet count ≥50,000\u002Fmm³ on or before Day 9 following the first infusion. The trial employs a single-group design, comparing outcomes to historical controls derived from the literature. Eligible patients must have a confirmed diagnosis of ITP with a platelet count ≤20,000\u002Fmm³ and no concurrent conditions likely to cause thrombocytopenia. Key exclusions include non-immune thrombocytopenia, active sepsis, pregnancy or lactation, hypersensitivity to blood products or IgG preparations, and various significant comorbidities (e.g., uncontrolled hypertension, severe hepatic or renal impairment, recent rituximab use). The intervention consists of V-IMMUNE® at a dose of 1 g\u002Fkg, administered once daily for two consecutive days, with infusion rates titrated from 0.01 mL\u002Fkg\u002Fmin to 0.06 mL\u002Fkg\u002Fmin. Standard pre-medication protocols (IV normal saline and diphenhydramine) are administered to mitigate infusion-related reactions and reduce the risk of thromboembolic events. Patients will be monitored at multiple time points from baseline through Day 90, with primary efficacy evaluation at Day 9. Secondary endpoints include duration of platelet response, overall treatment response rate, bleeding events, and incidence of infusion-related adverse events.",[102],"Immune Thrombocytopenia (ITP)",[104,105,106,107,108],"phase III","clinical trial","immune thrombocytopenia","human immunoglobulin","platelets","2026-01-15",{"date":111,"type":112},"2026-01-20","ACTUAL",{"date":114,"type":112},"2025-07-18",{"date":116,"type":96},"2027-02-27",{"name":5,"class":6},2]