[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Megalabs\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100435804","phase-1-biosimilarity-study-of-intravenous-recombinant-human-erythropoietin-in-healthy-volunteers-100435804",false,"NCT04954989","Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers","Phase I Open and Monocentric Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Intravenous Recombinant Human Erythropoietin in Male Adults.","RUBI","Inclusion Criteria:\n\n* Healthy eligible participants able to read, understand and sign the latest version of the Informed Consent Form (FICF) approved by the Research Ethics Committee (CEP);\n* Male participants aged between 18 and 55 years;\n* Be characterized as a healthy research participant, based on medical history, general physical examination and vital signs, laboratory tests and ECG not indicating any evidence of disease;\n* Present BMI ≥ 18 and ≤ 29.9 Kg\u002Fm2;\n* Have a body weight of 60 - 100 kg;\n* Present a negative test for coronavirus.\n\nExclusion Criteria:\n\n* Present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8°C), cough, dyspnea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospital stay (all periods);\n* Having had direct and significant contact, at the medical discretion, with people who tested positive for a coronavirus test within 14 days prior to the hospital stay (all periods);\n* Living in the same household as people who fall into the risk group of worse prognosis for coronavirus infection, such as individuals over 60 years old, individuals with respiratory problems, immunosuppressed or those with chronic diseases such as heart or diabetes (all periods );\n* Any clinical condition or laboratory alteration that, at the investigator's discretion, may compromise trial participation, ie:\n* Have an abnormal erythrocyte count (\\\u003C4.0 M\u002Fmm3 or \\>5.4 M\u002Fmm3);\n* Have an abnormal reticulocyte count (\\> 3.0%);\n* Have an abnormal platelet count (\\\u003C 135,000\u002FμL or \\> 550,000\u002FμL);\n* Have an abnormal hemoglobin level (\\\u003C 13g\u002FdL);\n* Have an abnormal level of hematocrit (\\\u003C40% or \\>54%);\n* Have an abnormal level of ferritin (\\\u003C 100 ng\u002FmL or \\> 336.2 ng\u002FmL);\n* Have an abnormal level of transferrin (\\\u003C 200 mg\u002FdL or \\> 360 mg\u002FdL);\n* Have an abnormal level of transferrin saturation (\\\u003C20%)\n* Have abnormal levels of vitamin B12 (\\\u003C 130 pg\u002FmL or \\>868 pg\u002FmL);\n* Present evidence of cardiovascular disorders, particularly arterial hypertension (supine blood pressure \\> 145 \u002F 90mmHg at baseline);\n* History of venous thrombosis;\n* Participants diagnosed with iron deficiency anemia or clinical history of autoimmune or hereditary anemia;\n* Clinical history of chronic or acute hemorrhages in the 30 days preceding the start of the trial;",true,"MALE","18 Years","55 Years",{"count":22,"type":23},52,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","Open label and monocentric Phase I Clinical Trial, to Determine the Pharmacokinetics and Pharmacodynamics of Recombinant Human Erythropoietin for Subcutaneous Use in an Adult Male Population",[29],"Healthy",[31],"reticulocytes","NOT_YET_RECRUITING","2024-08-16",{"date":35,"type":36},"2024-08-21","ACTUAL",{"date":38,"type":23},"2024-10-06",{"date":40,"type":23},"2024-12",{"name":42,"class":43},"Megalabs","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":19,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100543151","phase-3-comparative-study-of-two-recombinant-human-erythropoietin-products-in-chronic-kidney-disease-patients-100543151","NCT06352138","Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients","Phase III, Multicentre, Double-blind, Randomised, Parallel, Equivalence Clinical Trial to Assess Efficacy, Safety of Megalabs® Recombinant i\u002Fv Human Erythropoietin Compared to Epogen® in Anaemia in Patients With Chronic Kidney Disease","ENCASE","Inclusion Criteria:\n\n* Stage V Chronic kidney disease undergoing hemodialysis\n\nExclusion Criteria:\n\n* Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies","ALL","65 Years",{"count":56,"type":23},280,[58],"PHASE3","Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis",[61],"Anemia of Chronic Kidney Disease","2024-08-15",{"date":64,"type":36},"2024-08-19",{"date":66,"type":23},"2025-07",{"date":68,"type":23},"2027-03",{"name":42,"class":43},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":77,"targetDuration":4,"studyType":24,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100436095","phase-1-biosimilarity-study-of-subcutaneous-filgrastim-in-healthy-volunteers-100436095","NCT04958772","Biosimilarity Study of Subcutaneous Filgrastim in Healthy Volunteers","Clinical Trials Phase I, Single-Centric, Open, Randomized, Crossed, For Comparative Evaluation Of The Pharmacokinetic And Pharmacodynamic Profile Of The Filgrastim Injectable Solution, In Relation To The Comparison Granulokine®, Ltda. After Subcutaneous Multiple Administration In Healthy Participants","Inclusion Criteria:\n\n* Healthy eligible participants able to read, understand and sign the latest version of the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP)\n* Males aged between 18 and 55 years\n* Be characterized as a healthy research participant, based on medical history general physical examination and vital signs, laboratory tests and electrocardiogram (ECG),\n* Not indicating any evidence of disease\n* Body weight between 60-100 kg\n* Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 Kg \u002F m2\n* Negative test for coronavirus\n\nExclusion Criteria:\n\n* Present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8 ° C), cough, dyspnoea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospitalization period (all periods)\n* Direct and significant medical contact with people who tested positive for coronavirus testing within 14 days prior to the hospitalization period (all periods)\n* Living in the same household as people who are in the risk group with the worst prognosis for coronavirus infection, such as individuals over 60, individuals with respiratory problems, immunosuppressed or those with chronic diseases, such as heart or diabetes (all periods)\n* Participants diagnosed with malignant disease in the last 5 years, with the exception of successfully treated basal cell carcinoma\n* Participants with a previous diagnosis of severe asthma, sickle cell anemia, idiopathic urticaria or anaphylaxis\n* Participants with chronic diseases and, therefore, who regularly use medications\n* Being a smoker or quitting less than 6 months ago\n* Participants who consume more than 5 cups of tea or coffee a day and who cannot - abstain during the trial period\n* History of alcohol and illicit drug abuse\n* Electrocardiogram (ECG) findings that, at the investigator's discretion, may compromise participation in the trial\n* History or presence of gastrointestinal or liver diseases or any other condition that interferes with the absorption, distribution, excretion or metabolism of the drug\n* Use of lithium 2 weeks before and \u002F or after medication administration\n* Participants who are hypersensitive or contraindicated to use any of the components of the formulation\n* Research participants who have participated in clinical trial protocols in the last 12 (twelve) months (Resolution CNS 251, of August 7, 1997, item III, subitem J)\n* Have donated blood (\\> 500 mL) or have undergone major surgery in the 3 (three) months preceding the date of signing the informed consent form\n* Have received any vaccine in the 3 (three) months preceding the date of signing the informed consent form",{"count":78,"type":23},100,[26],"This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between filgrastim formulation, produced by Megalabs (test product) and Granulokine® (reference product) Amgen.",[29],{"date":33,"type":36},{"date":84,"type":23},"2024-11-01",{"date":86,"type":23},"2025-05-31",{"name":42,"class":43},""]