[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Octapharma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":231},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,72,96,118,146,169,189,211],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100543874","phase-3-study-of-iv-human-plasma-derived-c1-esterase-inhibitor-concentrate-in-patients-with-congenital-c1-inh-deficiency-for-treatment-and-pre-procedure-preventing-of-acute-hereditary-angioedema-attacks-100543874",false,"NCT06361537","Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks","Prospective, Multicenter, Randomized, Double-blind, Parallel Group, Placebo- Controlled, Efficacy and Safety Phase 3 Study of an Intravenous Human Plasma- Derived C1 Esterase Inhibitor (C1-INH) Concentrate in Participants With Congenital C1-INH Deficiency for the Treatment and Pre-procedure Prevention of Acute Hereditary Angioedema Attacks","Inclusion Criteria:\n\n1. Is at least 18 years of age (applicable for 1st study phase) or is at least 2 years of age (applicable for 2nd study phase)\n2. Has confirmed diagnosis of HAE type I or II\n3. Has had at least 3 moderate or severe HAE attacks (excluding extremity attacks) in the last 3 months before the Screening Visit. For participants ≥2 and ≤12 years of age, has had at least 1 moderate or severe HAE attack (excluding extremity attacks) in the last 6 months before Screening Visit\n4. Has a documented congenital C1-INH functional activity \\\u003C50% with or without C1-INH deficiency and C4 antigen level below the laboratory reference range\n5. Participant or the participant's legally authorized representative(s) has signed informed consent (as required by local law), with the assent of participants legally capable of providing it, as applicable\n6. States willingness to comply with all study procedures and availability for the duration of the study\n7. If the participant is of childbearing potential (CBP), has a negative pregnancy test and must have been using a highly effective method of contraception and continue to do so until at least 2 weeks after their last dose (for both blinded and open-label doses of IMP). Not of CBP is defined as surgically sterilized (hysterectomy, bilateral oophorectomy) or who are postmenopausal (defined as women with no menses for 12 months without an alternative medical cause). Highly effective methods of contraception:\n\n   * Combined hormonal contraception (estrogens and progesterone) methods such as oral, implantable, intravaginal, injectable, or transdermal contraceptives at a stable dose for a minimum of 1 full cycle (hormonal contraceptives must inhibit ovulation) and for at least 4 weeks before screening\n   * Progesterone only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n   * Intrauterine device\n   * Intrauterine hormone-releasing system inserted at least 4 weeks before screening\n   * Bilateral tubal ligation\u002Focclusion or vasectomized partner (with surgical success confirmed by medical assessment) OR Agrees to abstain from heterosexual intercourse during study participation and to use a highly effective contraceptive (as described above) as backup if they become sexually active during the study. Abstinence is only acceptable if this is the participant's usual lifestyle. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception\n   * Note: If a participant of CBP has a positive or suspected positive urine pregnancy test within 72 hours prior to treatment, a serum pregnancy test will be required\n   * Male participants must not plan to father a child or donate sperm for 90 days after their last dose of study drug (for both blinded and open-label doses of the IMP). However, there are no official contraception requirements for male participants during the study.\n\nInclusion Criteria for IMP Dosing for QAT:\n\n1. Has confirmed QAT per definition criteria\n2. Has a swelling episode that is new and not the continuation of a previous HAE attack\n\nExclusion Criteria:\n\n1. Has a history of clinically relevant antibody development against C1-INH\n2. Has a medical history consistent with Type 3 HAE (i.e., onset at age above 40 year, no family history, no known HAE mutation, low C1q level in plasma)\n3. Has a history of allergic reaction to C1-INH or other blood\u002Fplasma product\n4. Has a history of B-cell malignancy that was unresolved in the past 5 years\n5. Has a narcotic and\u002For alcoholic addiction\n6. Has participated in any other investigational drug evaluation within 30 days before screening\n7. Is pregnant or breastfeeding\n8. Has any clinically significant medical or psychiatric condition that, in the investigator's opinion would interfere with the participant's ability to participate in the study\n9. Has a history of thromboembolic events (TEEs), myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebrovascular accident, transient ischemic attack, severe peripheral vascular disease, or disseminated intravascular coagulation within one year before screening\n10. (applicable until IDMC review of the interim preliminary safety and efficacy data): has clinically significant derangement in measurements of cardiovascular status (i.e. uncontrolled arterial hypertension, cardiac insufficiency New York Heart Association (NYHA) class III-IV), pulmonary status (i.e., COPD GOLD classification 3 and 4, severe asthma) and renal status (i.e., eGFR below 90 ml\u002Fmin per 1.73 m2)\n\nExclusion Criteria for IMP Dosing for QAT:\n\n1. Has received blood or a blood product for prophylactic or acute treatment with any C1-INH (Berinert®, Cinryze®, HAEgarda®, Ruconest®, etc.), non-biological bradykinin and kallikrein pathway inhibitors (e.g., ecallantide, icatibant, berotralstat), or treatment with tranexamic acid within 14 days before dosing with the IMP (or is not willing to abstain from these medications throughout the study)\n2. started or changed hormone replacement therapy or selective estrogen receptor modulators (e.g., tamoxifen) within 14 days before IMP dosing\n3. Started or changed androgen therapy (e.g. testosterone, dehydro- epiandrosterone\u002Fandrostenedione, oxandrolone, danazol, stanozolol) within 14 days before IMP dosing or is not willing to maintain a stable dose throughout the study\n4. Started or changed the dose of monoclonal antibodies e.g. lanadelumab within 11 weeks before dosing or not willing to maintain a stable dose throughout the study\n5. Has used narcotic pain medications or non-opioid analgesics within 7 days before IMP dosing for a QAT\n6. Has received OCTA-C1-INH within 14 days before IMP dosing\n\nExclusion Criteria for IMP Dosing for PK:\n\n1. Has received blood or a blood product for prophylactic or acute treatment with any C1-INH (Berinert®, Cinryze®, HAEgarda®, Ruconest®, etc.), non-biological bradykinin and kallikrein pathway inhibitors (e.g., ecallantide, icatibant, berotralstat), or treatment with tranexamic acid within 14 days before dosing with the IMP (or is not willing to abstain from these medications throughout the study)\n2. Is receiving hormone replacement therapy or selective estrogen receptor modulators (e.g., tamoxifen) and has had their dose changed within 14 days before IMP dosing\n3. Is receiving or has received androgen therapy (e.g., testosterone, dehydroepiandrosterone\u002Fandrostenedione, oxandrolone, danazol, stanozolol) IN ANY DOSE within 14 days before dosing\n4. Started or changed the dose of monoclonal antibodies e.g lanadelumab within 11 weeks before dosing or not willing to maintain a stable dose throughout the study\n5. Has used narcotic pain medications or non-opioid analgesics within 7 days before IMP dosing\n6. Has received IMP within 14 days before IMP dosing\n7. Has planned dental, medical, or surgical procedures during the PK Period that will require pre-procedural prevention","ALL","2 Years",{"count":19,"type":20},124,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks",[26],"Acute Hereditary Angio Edema",[28,29,30,31,32],"Edema","Swelling","Angio Edema","Hereditary","Congenital Angioedema","RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":37},"2024-04-30",{"date":41,"type":20},"2027-06",{"name":43,"class":44},"Octapharma","INDUSTRY",21,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100609925","phase-3-supporting-weak-immune-system-during-autoimmune-therapy-testing-panzyga-to-prevent-infections-100609925","NCT07220915","Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients With Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment With B-cell Depletion Therapy (\"PROTECT\")","Inclusion Criteria:\n\nPatients who meet all of the following criteria will be eligible to participate in the study:\n\n1. Are ≥18 years of age at time of informed consent, have been diagnosed with a rheumatic or autoimmune condition, received their last BCDT dose within 3 months of Screening, and have the intention to receive BCDT during study participation. Note: Patients with the following indications are eligible: MS, RA, vasculitis\u002Fmyositis, SLE, SS, IIM, MCTD, UCTD, myasthenia gravis, autoimmune encephalitis, CIDP, and neuromyelitis optica spectrum disorder). Other rheumatic and autoimmune conditions may also be acceptable with approval from the Medical Monitor.\n2. Have hypogammaglobulinemia (IgG levels \\\u003C5 g\u002FL as confirmed by the central laboratory).\n3. Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements..\n4. Are willing and able to comply with a highly effective contraception method during and for 30 days after the treatment period. Contraceptive use by men and women of childbearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from participation in the study:\n\n1. Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component\n2. Have a current major infection at Screening or had \\>1 major infection within 6 months prior to Baseline\n3. Have a history of thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, or peripheral artery disease (Fontaine IV) within 6 months prior to Baseline\n4. Have a known IgA deficiency with antibodies to IgA\n5. Have a known blood hyperviscosity or other hypercoagulable states\n6. Have been diagnosed with primary immunodeficiency.\n7. Have a severe liver disease, with signs of ascites or hepatic encephalopathy\n8. Have a severe kidney disease (as defined by eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n9. Have a body weight \\>140 kg\n10. HIV infection at Screening (defined for the study as positive HIV NAT test or reactive HIV- 1\u002F2 antigen\u002Fantibody immunoassay followed by positive HIV-1\u002FHIV-2 antibody differentiation immunoassay)\n11. Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and\u002For low HBV titers, who will not receive targeted antiviral therapy while participating in the study, and patients with active HBV, defined as high HBV titers.\n12. Uncontrolled hepatitis C infection at Screening (defined for the study as positive HCV PCR).\n13. Have received IgG treatment within 6 months prior to Screening or plan to receive IgG therapy, other than IMP, during the study\n14. Are receiving or plan to receive immunosuppressive treatment (other than for underlying condition) or other forbidden medication during the entire study duration\n15. Are participating or plan to participate in another study that is either blinded or involves an investigational medicinal product within 3 months prior to Baseline or during the course of this study. Participation in observational or open-label studies involving an approved product may be permitted after consultation with the Medical Monitor.\n16. If female, are pregnant or lactating\n17. Are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development, in the opinion of the Investigator","18 Years",{"count":55,"type":20},360,[23],"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy",[59,60,61,62],"Hypogammaglobulinemia","Autoimmune Conditions","Rheumatic Conditions","Infections","NOT_YET_RECRUITING","2026-06-16",{"date":66,"type":37},"2026-06-17",{"date":68,"type":20},"2026-06",{"date":70,"type":20},"2029-12",{"name":43,"class":44},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100432981","phase-3-efficacy-of-atenativ-in-patients-with-congenital-antithrombin-deficiency-undergoing-surgery-or-delivery-100432981","NCT04918173","Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery","A Multicenter, Prospective, Open-label, Uncontrolled Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery","Inclusion Criteria:\n\n1. Adult male or female patients ≥18 and ≤80 years of age. Solely in the US, 4 male or female patients between ≥12 and \\\u003C17 years of age will be enrolled into the PK phase, and subsequently in the treatment phase, if applicable\n2. Documented congenital antithrombin deficiency, defined by plasma activity level of antithrombin ≤60% from medical history\n3. Personal or family history of TEs or TEEs (except for PK patients)\n4. For the Treatment Phase: either a) non-pregnant surgical patients scheduled for elective surgical procedure(s) known to be associated with a high risk for occurrence of TEs or TEEs, or b) pregnant patients of at least 27 weeks gestational age who are scheduled for caesarean section or delivery\n5. For female patients of childbearing potential entering the PK Phase who are not known to be pregnant, and for female surgical patients of childbearing potential entering the Treatment Phase for any procedure other than caesarean section or delivery, a negative urine pregnancy test at screening and at baseline\n6. Patient has provided informed consent\n\nExclusion Criteria:\n\n1. Requires emergency surgery or emergency caesarean section\n2. Has undergone surgery within the last 6 weeks\n3. History or suspicion of another hereditary thrombophilic disorder other than antithrombin deficiency (e.g., activated protein C \\[APC\\] resistance\u002FFactor V Leiden, Protein S or C deficiency, prothrombin gene mutation \\[G20210A\\], or acquired \\[lupus anticoagulant\\] thrombophilic disorder)\n4. Malignancies, renal failure (patients on renal replacement therapy), or severe liver disease (aspartate aminotransferase \\[ASAT\\] \\>5 times the upper limit of normal)\n5. Body mass index \\>40 kg\u002Fm2 (for non-pregnant patients, only)\n6. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ\n7. History of anaphylactic reaction(s) to blood or blood components\n8. Refusal to receive transfusion of blood-derived products\n9. Administration of any antithrombin concentrate or antithrombin-containing blood product within 14 days of either of the two phases of the study\n10. Prior diagnosis of heparin-induced thrombocytopenia\n11. TE or TEE within the last 6 months\n12. Female patients who are nursing at the time of screening\\*\n13. Have participated in another investigational study within the last 30 days\n14. Persons dependent on the sponsor, the investigator or the centre of investigation\n15. Persons placed in an institution by administrative or judicial order\n\n    * criterion does not include female patients who plan to breastfeed after giving birth","12 Years","80 Years",{"count":82,"type":20},38,[23],"The goal of this study is to assess the incidence of the composite of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under when they receive Atenativ for surgical procedures or parturition.",[86],"Congenital Antithrombin Deficiency","2026-06-02",{"date":89,"type":37},"2026-06-03",{"date":91,"type":37},"2022-07-01",{"date":93,"type":20},"2026-12-01",{"name":43,"class":44},30,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100339167","efficacy-safety--utilisation-of-nuwiq-octanate-and-wilate-in-previously-untreated--minimally-treated-haemophilia-a-patients-100339167","NCT03695978","Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients","Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment With Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW","Protect-NOW","Inclusion Criteria:\n\n* Male and female patients of any age and ethnicity\n* Severe haemophilia A (FVIII:C\\\u003C1%)\n* Decision to prescribe Octapharma's FVIII concentrate before enrollment into the study\n* Either\n* No previous treatment with FVIII concentrates or other blood products containing FVIII (PUPs) OR\n* Less than 5 Exposure Days (EDs) to FVIII concentrates or other blood products containing FVIII (MTPs), if\n* data are available on all previous treatment, AND\n* they did not develop an inhibitor at any time point, OR\n* they developed an inhibitor during treatment with an Octapharma FVIII concentrate AND continue treatment with THIS Octapharma FVIII concentrate (in the presence or absence of emicizumab).\n* Voluntarily given, fully informed written and signed consent obtained before any study-related data documentation is conducted (obtained from the patient's parent\u002Flegal guardian)\n\nExclusion Criteria:\n\n* Diagnosis with a coagulation disorder other than haemophilia A\n* Concomitant treatment with any systemic immunosuppressive drug\n* Participation in an interventional clinical trial during the time period evaluated\n* Participation in another non-interventional study of Octapharma",{"count":105,"type":20},200,"OBSERVATIONAL","International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.",[109],"Haemophilia A","2026-05-29",{"date":87,"type":37},{"date":113,"type":37},"2018-02-13",{"date":115,"type":20},"2030-06",{"name":43,"class":44},59,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100523471","phase-3-phase-3-study-on-the-efficacy-and-safety-of-human-plasma-derived-antithrombin-atenativ-in-heparin-resistant-patients-scheduled-to-undergo-cardiac-surgery-necessitating-cardiopulmonary-bypass-100523471","NCT06096116","Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass","Phase 3, Double-blind, Placebo-controlled, Multicentre Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass","Inclusion Criteria:\n\n1. Planned cardiac surgery with CPB\n2. Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U\u002Fkg UFH)\n3. Patients between 18 and 85 years of age, inclusive\n4. Freely given written or electronic informed consent\n5. In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery\n\nExclusion Criteria:\n\n1. Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:\n\n   1. vitamin K antagonists (within 3 days)\n   2. direct oral anticoagulants (within 2 days)\n   3. thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory according to local standard of care assessment\n   4. ticagrelor (within 5 days), unless platelet function is satisfactory according to local standard of care assessment\n   5. glycoprotein IIb\u002FIIIa antagonist (within 24 hours)\n2. Pre-existing coagulopathy, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)\n3. Renal insufficiency, defined as serum creatinine level \\>2.0 mg\u002FdL\n4. Thrombocytosis, defined as platelet count \\>400,000 per μL\n5. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ, i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid\n6. History of anaphylactic reaction(s) to blood or blood components\n7. Refusal to receive transfusion of blood or blood-derived products\n8. Current participation in another interventional clinical trial or previous participation in the current trial\n9. Treatment with any IMP within 30 days prior to screening visit","85 Years",{"count":127,"type":20},120,[23],"The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)",[131],"Acquired Antithrombin Deficiency",[133,134,135,136],"heparin resistance","antithrombin deficiency","cardiopulmonary bypass","cardiac surgery","2026-05-08",{"date":139,"type":37},"2026-05-12",{"date":141,"type":37},"2024-08-21",{"date":143,"type":20},"2028-03",{"name":43,"class":44},27,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":154,"minAge":79,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},"100511124","phase-4-nuwiq-for-perioperative-management-of-patients-with-haemophilia-a-on-emicizumab-regular-prophylaxis-study-100511124","NCT05935358","Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study","Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study (NuPOWER)","NuPOWER","Inclusion Criteria:\n\n* Severe haemophilia A (FVIII activity \\[FVIII:C\\] \\\u003C1%) according to medical history\n* Male patients at least 12 years of age\n* Previous treatment with any FVIII product(s) for at least 150 exposure days\n* On regular prophylaxis with emicizumab for at least 1 month prior to a scheduled major elective surgery requiring FVIII treatment\n* Freely given written informed consent of the patient, or parent\u002Flegal representative where applicable, obtained in accordance with local regulations\n\nExclusion Criteria:\n\n* Coagulation disorder other than haemophilia A\n* Present or past FVIII inhibitor (≥0.6 Bethesda units \\[BU\\]\u002FmL) according to medical history\n* Severe liver or kidney disease (alanine aminotransferase \\[ALT\\] and\u002For aspartate aminotransferase \\[AST\\] levels \\>5 times the upper limit of normal; or creatinine \\>120 μmol\u002FL)\n* Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)\n* Already had surgery in this study\n* Current participation in another interventional clinical trial\n* Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit","MALE",{"count":156,"type":20},28,[158],"PHASE4","Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis",[161],"Severe Hemophilia A",{"date":139,"type":37},{"date":164,"type":37},"2023-11-28",{"date":166,"type":20},"2026-09",{"name":43,"class":44},18,{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":176,"minAge":79,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100511218","phase-4-nuwiq-dosing-and-outcomes-in-the-management-of-womengirls-with-haemophilia-a-needing-fviii-treatment-for-surgery-100511218","NCT05936580","Nuwiq Dosing and Outcomes In the ManagEment of Women\u002FGirls With Haemophilia A Needing FVIII Treatment for Surgery","Nuwiq Dosing and Outcomes In the ManagEment of Women\u002FGirls With Haemophilia A Needing FVIII Treatment for Surgery - an International, Open-label, Non-controlled Study (NuDIMENSION)","Inclusion Criteria:\n\n1. Women\u002Fgirls with haemophilia A (FVIII:C ≥1-\\\u003C40%) according to medical history. Additionally, women\u002Fgirls with documented FVIII activity levels between ≥ 40% and 50% may be included if there is a documented history of clinically significant bleeding episodes consistent with haemophilia A; and\u002For either documented prior treatment with FVIII concentrates or a clinical indication that FVIII treatment would have been appropriate (e.g., use of FVIII from a family member, or treatment with alternative haemostatic agents due to access limitations)\n2. At least 12 years of age\n3. Scheduled to undergo major surgery\\* requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A\n4. Freely given written informed consent of the patient, or parent\u002Flegal representative where applicable, obtained in accordance with local regulations\n\nExclusion Criteria:\n\n1. Coagulation disorder other than haemophilia A\n2. Present or past FVIII inhibitor (≥0.6 Bethesda units \\[BU\\]\u002FmL)\n3. Severe liver or kidney disease (alanine aminotransferase \\[ALT\\] and\u002For aspartate aminotransferase \\[AST\\] levels \\>5 times the upper limit of normal; or creatinine \\>120 μmol\u002FL)\n4. Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)\n5. Pregnancy, except in participants with a planned caesarean section\n6. Already had surgery in this study\n7. Current participation in another interventional clinical trial\n8. Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit","FEMALE",{"count":156,"type":20},[158],"Recombinant factor VIII for the prevention of bleeding in women\u002Fgirls with haemophilia A undergoing major surgery",[181],"Hemophilia A",{"date":139,"type":37},{"date":184,"type":20},"2026-04",{"date":186,"type":20},"2027-02",{"name":43,"class":44},16,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},"100549113","post-marketing-observational-study-on-safety-of-balfaxar-vs-kcentra-for-reversal-of-vitamin-k-antagonist-induced-anticoagulation-in-adults-undergoing-urgent-surgery-or-invasive-procedure-100549113","NCT06429787","Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure","Post Marketing Observational Study on Safety of BALFAXAR® vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure.","Inclusion Criteria:\n\n1. Subjects at least 18 years of age.\n2. Subjects on VKA treatment.\n3. Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure.\n\nExclusion Criteria:\n\n1. History of TEE within 90 days before receipt of VKA reversal therapy.\n2. Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.",{"count":197,"type":20},3574,"Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure",[200,201],"Vitamin K-Dependent Coagulation Defect","Significant Bleeding Risk","2025-06-03",{"date":204,"type":37},"2025-06-04",{"date":206,"type":37},"2025-02-14",{"date":208,"type":20},"2032-06-30",{"name":43,"class":44},1,{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":21,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":229,"locationsCount":230},"100433831","phase-3-study-to-evaluate-safety-and-efficacy-of-different-panzyga-dose-regimens-in-pediatric-chronic-inflammatory-demyelinating-polyradiculoneuropathy-cidp-patients-100433831","NCT04929236","Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients","Multicenter, Prospective, Double-Blinded, Parallel Group, Randomized Phase III Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients","Inclusion Criteria:\n\n1. Age ≥2 years and ≤17 years.\n2. Patients with a diagnosis of CIDP based on European Academy of Neurology\u002FPeripheral Nerve Society (EANPNS) 2021 guidelone \\[1\\]\n3. Clinical history of functional impairment due to CIDP, corresponding to an mRS score ≥2, but ≤5.\n4. Voluntarily given written informed consent (provided by patient's parent or legal guardian) and assent (provided by the patient, if age appropriate per Independent Ethics Committee \\[IEC\\]\u002FInstitutional Research Board \\[IRB\\] requirements).\n\nExclusion Criteria:\n\n1. Patients with previously diagnosed CIDP who lack any CIDP symptoms.\n2. Patients with a known history of inherited neuropathy or a family history of inherited neuropathy.\n3. Patients who have previously failed immunoglobulin therapy for CIDP.\n4. Patients who received immunoglobulin or plasma exchange (PEX) within eight weeks prior to the Baseline Visit (washout phase). However, if a patient has clinical evidence of confirmed CIDP relapse during the washout phase (consistent with an increase in mRS of ≥1), they are eligible for trial enrolment.\n5. Patients with a history of deep vein thrombosis (DVT) in the past year, or pulmonary embolism ever.\n6. Patients on unstable (change in prescribed dose within the last eight weeks) corticosteroids or rituximab use.\n7. Patients with known or suspected hypersensitivity, anaphylaxis, or severe systemic response to immune-globulins, blood or plasma derived products, or any component of PANZYGA.\n8. Female patients who are breastfeeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method while on the study (acceptable methods of birth control for this study include: intrauterine device \\[IUD\\], hormonal contraception, male or female condom, spermicide gel, diaphragm, sponge, or cervical cap).\n9. Presence of medical history information or clinical symptoms suggestive of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and\u002For hepatitis C virus (HCV) infections.\n10. Severe liver and\u002For kidney disease (alanine aminotransferase \\[ALT\\] \\> 3 × upper limit of normal \\[ULN\\]; aspartate aminotransferase \\[AST\\] \\> 3 × ULN; and\u002For creatinine levels \\>44 µmol\u002FL for children ages 2-3 years, \\>62 µmol\u002FL for children ages 4-10 years, and \\>89 µmol\u002FL for children ages 11-17 years.\n11. Presence of medical history information or clinical symptoms suggestive of immunoglobulin (IgA) deficiency and antibodies against IgA.\n12. History of alcohol or drug abuse in the previous year, per Investigator's opinion.\n13. Unable or unwilling to comply with the study protocol.\n14. Receipt of any other investigational medicinal product (IMP) within three months before study entry or participating in another interventional clinical study. Prior participation in an observational or open-label study involving an approved product may be allowed but require prior consultation with the Medical Monitor to assess eligibilty.\n15. Any other condition(s) that, in the Investigator's opinion, makes it undesirable for the patient to participate in the study or may interfere with protocol compliance.","17 Years",{"count":95,"type":20},[23],"Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients",[223],"Pediatric Chronic Inflammatory Demyelinating Polyneuropathy",{"date":225,"type":37},"2025-06-06",{"date":227,"type":37},"2023-10-01",{"date":68,"type":20},{"name":43,"class":44},6,""]