[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"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":20,"type":21},31,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Immune Thrombocytopenia (ITP)",[29,30,31,32,33],"phase III","clinical trial","immune thrombocytopenia","human immunoglobulin","platelets","RECRUITING","2026-01-15",{"date":37,"type":38},"2026-01-20","ACTUAL",{"date":40,"type":38},"2025-07-18",{"date":42,"type":21},"2027-02-27",{"name":44,"class":45},"On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":75,"locationsCount":76},"100589440","phase-3-v-immune-a-novel-immunoglobulin-therapy-for-immunodeficiency-100589440","NCT06954441","V-IMMUNE: A Novel Immunoglobulin Therapy for Immunodeficiency","V-IMMUNE® for Primary Immunodeficiency: A Phase III Clinical Trial (VIP Study)","VIP","Inclusion Criteria:\n\n* Patients aged 2 years or older;\n* Primary immunoglobulin G deficiency, already receiving another intravenous immunoglobulin (IVIG). Primary IgG deficiency may be secondary (non-exhaustive list) to one of the following diagnoses:\n* Agammaglobulinemia due to absence of B cells\n* Hypogammaglobulinemia with reduced antibody function - variable common immunodeficiency complex\n* Quantitative and functional deficiencies of immunoglobulin G\n* Normal immunoglobulin with reduced capacity for antibody production after immunization (e.g., Wiskott-Aldrich syndrome, IgG subclass deficiency, antipolysaccharide antibody deficiency against Haemophilus or pneumococcus)\n* Severe combined immunodeficiencies: DiGeorge syndrome presenting with immunoglobulin G deficiency\n* Isotype-switching defects: hyperimmunoglobulinemia M syndromes\n* Two trough IgG measurements ≥500 mg\u002FdL within the past 90 days.\n* Participants with through IgG measurements ≥700 mg\u002FdL within the last 30 days before the first visit\n\nExclusion Criteria:\n\n* Acute infection under treatment within 2 weeks prior to screening\n* Pregnancy\n* History of hypersensitivity reaction to blood or blood products\n* Previous anaphylactic reaction to IgG\n* Intolerance to any component of V-Immune\n* IgA deficiency, history of reactions to products containing IgA, or history of anti-IgA antibodies\n* Selective Deficiency of IgA, IgM, IgD, or IgE\n* Participation in any other study involving an investigational product\n* Exposure to blood or any blood-derived products in the last 3 months\n* Known HIV, HCV, or HBV infection\n* ALT \\>3× the upper limit of normal or 3x baseline value\n* Serum creatinine \\>2× the upper limit of normal or 2x baselline value\n* BUN \\>2.5× the upper limit of normal or 2.5x baseline value\n* History of NYHA class III\u002FIV heart failure\n* Uncontrolled hypertension with systolic BP \\>160 mmHg or diastolic BP \\>100 mmHg\n* History of thrombotic events such as DVT, MI, stroke, or PE within the last 6 months\n* Neoplasia under treatment\n* Severe hepatic, renal, or cardiac insufficiency\n* Child-Pugh class B\u002FC hepatic insufficiency\n* Alcohol, opioid, or psychotropic drug abuse within the last 12 months\n* Use of immunosuppressive agents\n* Long-term use of prednisone \\>10 mg\u002Fday or equivalent\n* Protein-losing enteropathies (Crohn's disease, ulcerative colitis, Ménétrier's disease, celiac disease)\n\nObservation:\n\nIf Research participant becomes pregnant during study participation - we will Discontinue any further administration of the IMP; The principal investigator must refer the research participant for follow-up through routine healthcare services; The research participant will continue to be monitored by the study; Obtain informed consent from the pregnant participant to request authorization to follow her pregnancy; If authorized by a specific informed consent form, even after the participant's involvement in the study has ended, the investigator must contact the pregnant participant quarterly to monitor the pregnancy. The results of this follow-up must be entered into the CRF. The frequency will be maintained as long as no abnormalities are identified in the participant, the pregnancy, or the fetus.\n\nFemale partner of a male research participant becomes pregnant during the study = No action is required regarding the research participant's participation; Obtain informed consent from the research participant's partner to request authorization to monitor her pregnancy. If authorized by a specific informed consent form, the investigator must contact the pregnant woman quarterly to monitor the pregnancy. The results of this follow-up must be entered into the CRF. The frequency will be maintained as long as no abnormalities are identified in the pregnant woman, the pregnancy, or the fetus.\n\nData Confidentiality:\n\nThe confidentiality of data from all patients will be ensured and preserved. Patient identification will be performed exclusively through the study-assigned identification number, the patient's initials, and date of birth. An exception to this procedure applies to participants included in the pharmacokinetic analyses, who, after providing consent themselves or through their legal representative, will also have their personal identifying data (full name, CPF \\[Brazilian individual taxpayer registry number\\], date of birth, and sex), as well as information regarding their participation (date of study enrollment), collected and transferred to the ICF laboratory for registration in the SINEB system (Sistema de Informações de Estudos de Equivalência Farmacêutica e Bioequivalência), an ANVISA database used for the registration of participants in studies of this nature.\n\nData obtained from medical records and other documents will be maintained in a confidential manner by the research centers and stored in locations with restricted access limited to the study team. Sensitive data, such as patient contact information collected for scheduling and follow-up purposes, will be accessed exclusively by personnel involved in the conduct of the study. The principal investigator shall allow direct access to participants' records and source documents for the purposes of monitoring, auditing, or inspection by the Sponsor and Regulatory Authorities, if required.\n\nWith regard to participants included in the pharmacokinetic analyses, the collection of personal identifying data (full name, CPF \\[Brazilian individual taxpayer registry number\\], date of birth, and sex) and participation-related information (date of study enrollment) is planned for transfer to the ICF laboratory for registration in the SINEB database. This procedure aims to mitigate risks to research participants by ensuring that they are not concurrently enrolled in another study within an interval shorter than six (6) months.","2 Years",{"count":56,"type":21},50,[24],"This is a phase III, non-randomized clinical trial (VIP Study) designed to assess the safety and efficacy of V-IMMUNE®, a 5% human normal immunoglobulin preparation, in approximately 50 patients with primary immunodeficiency (PID). Participants, all aged ≥2 years and already receiving IVIG therapy, will be switched to V-IMMUNE® at a dose of 600 mg\u002Fkg every three weeks via intravenous infusion. The study will use historical data as a control and extend over 12 months, with scheduled visits at each infusion (an estimated 17 infusions per participant).\n\nObjectives and Outcomes Primary Efficacy Endpoint: Rate of serious bacterial infections over 12 months. Primary Safety Endpoint: Proportion of infusions with one or more temporally associated adverse events (AEs).\n\nSecondary Endpoints: Additional safety outcomes (e.g., average number of AEs within 72 hours per infusion), efficacy measures (non-serious bacterial infections, time to resolution, antibiotic use, hospitalizations), and quality of life (SF-36) at 6 and 12 months. A pharmacokinetic (PK) sub-study will be conducted in 20 participants aged ≥16 years to evaluate total IgG levels, half-life, AUC, Cmax, and other PK parameters.\n\nStudy Design and Intervention V-IMMUNE® is given at an initial infusion rate of 0.01 mL\u002Fkg\u002Fmin for 30 minutes, increasing stepwise up to 0.06 mL\u002Fkg\u002Fmin if well tolerated. Pre-medication, including rapid IV saline, diphenhydramine, and hydrocortisone, will be administered for the first three months to reduce the risk of infusion-related AEs. Patients at elevated thromboembolic risk will receive the lowest feasible infusion rate.\n\nSample Size and Analysis Fifty patients total will be enrolled to ensure adequate power to demonstrate a severe infection rate below one event per person-year (with a one-sided 1% significance level). Safety endpoints will be met if the upper bound of the 95% confidence interval for the proportion of temporally associated infusion-related AEs remains below 40%, assuming a true rate under 20%. An interim analysis is planned at six months or upon reaching 50% enrollment.\n\n20 patients at total including adults and \\\u003C16 years old, 6 children from 2 to 12 years old and 6 children from 12 to 16 years old.",[60,61,62],"Immunodeficiencies","Primary Immunodeficiencies (PID)","Agammaglobulinemia",[64,65,66,67,68,69,70],"immunodeficiency","intravenous immunoglobulin","pharmacokinetics","safety","efficacy","serious bacterial infection","temporally related adverse event",{"date":37,"type":38},{"date":73,"type":38},"2025-08-15",{"date":42,"type":21},{"name":44,"class":45},1,""]