[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kedrion S.p.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":116},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,76,101],{"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},"100573905","phase-3-a-study-investigating-intravenous-human-normal-immune-globulin-igiv-10-kig10-qivigy-in-subjects-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100573905",false,"NCT06752356","A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Double-blind, Randomized, Multi-Center Study Investigating Efficacy and Safety of Two Different Dosages of Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Inclusion Criteria:\n\n1. Male or female, aged ≥18 years.\n2. Written informed consent and authorization to access personal health information obtained independently from participants indicating that they understand the purpose of, and procedures required for, the study and are willing to participate.\n3. Documented diagnosis of CIDP consistent with the 2021 European Academy of Neurology\u002FPeripheral Nerve Society (EAN\u002FPNS) criteria.\n4. Current or documented history of significant disability, as defined by an overall INCAT disability score between 2 and 9. A score of 2 must be exclusively from the lower extremities.\n5. Participants are currently dependent on treatment with immunoglobulins, corticosteroids, or standard of care treatments for CIDP.\n6. Weakness of at least two limbs.\n7. Participants should be clinically stable 12 weeks prior to screening date as defined by:\n\n   * without a worsening in INCAT score of ≥1 point, AND\u002FOR without significant changes in clinical symptoms AND\n   * without significant dose changes or requiring additional treatments.\n\nExclusion Criteria:\n\n1. Patients' incapable of giving informed consent.\n2. Pure sensory and other CIDP variants.\n3. Females who are pregnant, breastfeeding, unwilling to practice effective birth control methods as defined in Appendix C throughout the study, or planning a pregnancy during the study.\n4. IG-experienced participants requiring an IGIV dosage of more than 1.4 g\u002Fkg\u002Fmonth OR SCIG pre-treated participants requiring a SCIG dosage of more than 1.6 g\u002Fkg\u002Fmonth.\n5. Participants who have previously failed to respond to IGIV or SCIG.\n6. On screening date, a body mass index (BMI) \\> 35 kg\u002Fm2 or an IGIV dose that puts the patient at risk of fluid overload.\n7. CIDP and any neuropathy of other causes not consistent with the 2021 EAN\u002FPNS criteria including:\n\n   1. Hereditary demyelinating neuropathies, such as a hereditary sensory and motor neuropathy (HSMN) (Charcot-Marie-Tooth \\[CMT\\] disease), and hereditary sensory and autonomic neuropathies (HSANs).\n   2. Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, osteosclerotic myeloma, diabetic and non-diabetic lumbosacral radiculoplexopathy or neuropathy, lymphoma, and amyloidosis.\n   3. Multifocal motor neuropathy (MMN).\n   4. Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy. Peripheral neuropathy induced by vitamin B12 deficiency.\n8. Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with increased titers of antibodies to myelin-associated glycoprotein.\n9. Central demyelinating disorders (e.g, multiple sclerosis) or severe myopathy.\n10. Any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of CIDP or outcome measures (e.g., severe arthritis, stroke, Parkinson's disease, and diabetic peripheral neuropathy) \\[participants with clinically diagnosed diabetes mellitus, who have adequate glycemic control with Hemoglobin A1C (HbA1C) of \\\u003C7.5% at screening, and who agree to maintain adequate glycemic control during the study are allowed\\].\n11. Congestive heart failure (New York Heart Association (NYHA) Class III\u002FIV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension \\[i.e., diastolic blood pressure \\>100 mmHg and\u002For systolic blood pressure \\>160 mmHg\\]. If a single measure exceeds this limit, a triple repeat measurement may be performed and the average of the three measurements used.\n12. History of deep vein thrombosis or thromboembolic events (e.g, cerebrovascular accident, pulmonary embolism) in the past 12 months.\n13. Condition(s) which could alter protein catabolism and\u002For IgG utilization (e.g, protein-losing enteropathies, nephrotic syndrome).\n14. Known history of chronic kidney disease, or glomerular filtration rate (GFR) of \\\u003C60 milliliter per minute per 1.73 square meter (mL\u002Fmin\u002F1.73m2) estimated based on an established chronic kidney disease epidemiology collaboration (CKD-EPI) equation at the time of screening.\n15. Active malignancy requiring chemotherapy and\u002For radiotherapy, or history of malignancy with less than 2 years of complete remission prior to screening. Exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment.\n16. Hypersensitivity or adverse reactions (e.g, urticaria, breathing difficulty, severe hypotension, or anaphylaxis) to human blood products such as human IgG, albumin, or other blood components.\n17. Known history of immunoglobulin A (IgA) deficiency.\n18. Known history of autoimmune nodo-paranodopathies causing IG treatment resistance, including anti-neurofascin (NF) 186 antibodies and antibodies against paranodal proteins, such as NF155, contactin 1 (CNTN1), and contactin-associated protein 1 (CASPR1).\n19. Abnormal laboratory values at screening:\n\n    1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\> 2.5x upper limit of normal (ULN)\n    2. Platelet count \\\u003C100,000 cells\u002FµL.\n    3. Absolute neutrophil count (ANC) \\\u003C1000 cells\u002FµL.\n    4. Clinically significant anemia or hemoglobin (Hgb) level of \\\u003C 10.0 g\u002FdL at screening.\n20. Ongoing\u002Factive infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV Type 1\u002F2 infection. Participants with chronic hepatitis B or hepatitis C infection currently on treatment may participate if they have undetectable viral load within 12 months of screening date.\n21. Subjects who have received:\n\n    1. Within 2 months before wash-out phase:\n\n       * PE\n       * change in treatment of methotrexate, azathioprine, or mycophenolate\n    2. Within 3 months before wash-out phase: Efgartigimod alfa (Vyvgart)\n    3. Within 5 months before wash-out phase: cyclophosphamide, interferon, tumor necrosis factor-alpha inhibitors, fingolimod, or any other immunosuppressive medications\n    4. Within 12 months before wash-out phase: rituximab or alemtuzumab\n22. Participants who have received a hematopoietic stem cell transplant.\n23. Participants on corticosteroids for the treatment of CIDP after being fully washed out. Participants on maintenance doses of corticosteroid may be allowed, if treatment is for conditions unrelated to CIDP (doses usually below 20 mg\u002Fday prednisone or equivalent and where the dosage is unlikely to be tapered during the duration of the trial may be allowed for indications other than CIDP).\n24. Any disorder or condition that in the investigator's judgment may impede the participant's participation in the study, pose increased risk to the participant, or confound the results of the study.\n25. Participation in another clinical study involving an investigational medicinal product (IMP) or investigational device within 30 days prior to screening visit or within 5 half-lives of the IMP under investigation or is scheduled to participate in another clinical study involving an IMP or investigational device during the intended course of this study.\n26. History of acquired or inherited thrombophilic disorders. These will include the specific types of acquired or inherited thrombophilic disorders that could put participants at risk of developing thrombotic events. Examples include, but are not restricted to:\n\n    1. Hereditary thrombophilia, examples include\n\n       * Factor V Leiden mutation.\n       * Prothrombin 20210A mutation.\n       * Protein C deficiency.\n       * Protein S deficiency.\n       * Antithrombin deficiency.\n    2. Acquired thrombophilias, examples include:\n\n       * Antiphospholipid antibody syndrome.\n       * Activated protein C Resistance acquired.\n       * Homocysteinemia.\n27. Previous participation in this clinical study, except for participants who withdrew consent during the washout phase, prior to randomization.\n28. Any other factor that, in the opinion of the investigator, would prevent the subject from complying with the requirements of the protocol.","ALL","18 Years",{"count":19,"type":20},161,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The current study is being conducted to assess the efficacy and safety of KIg10 (Intravenous Human Immune globulin 10%) at two different dosages as maintenance therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) following 21 weeks of treatment.",[26],"Chronic Inflammatory Demyelinating Polyneuropathy",[26,28,29,30,31,32],"CIDP","Intravenous","Human Immunoglobulin","KIg10","QIVIGY","RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":20},"2026-06",{"date":41,"type":20},"2027-12-27",{"name":43,"class":44},"Kedrion S.p.A.","INDUSTRY",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100597477","phase-3-a-study-investigating-intravenous-human-normal-immunoglobulin-10-in-adults-with-chronic-immune-thrombocytopenia-itp-100597477","NCT07059000","A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)","A Phase III, Open-label, Single Arm, Prospective, Multicenter Study to Assess Efficacy and Safety of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Adult Patients With Chronic Immune Thrombocytopenia (ITP)","ITP","Inclusion Criteria:\n\n1. Male or female, 18-70 years of age.\n2. Patient has signed the ICF.\n3. Diagnosis of chronic (\\> 12 months duration) ITP as defined by the International Working Group.\n4. Mean screening platelet count of \\\u003C 30 × 10\\^9\u002FL from two qualifying counts measured at least one calendar day apart. The first qualifying count can be from historical data if measured within 7 days prior to screening. The second qualifying count will be measured within 7 days before the first KIg10 infusion.\n5. A pre-infusion platelet count of \\\u003C 30 × 10\\^9\u002FL at the Baseline Visit.\n6. Patient is willing to comply with all requirements of the protocol.\n7. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening and agree to employ adequate birth control measures during the study.\n8. Authorization to access personal health information.\n\nExclusion Criteria:\n\n1. Patients incapable of giving informed consent.\n2. Patients with secondary ITP (all forms of immune-mediated thrombocytopenia except primary ITP). e.g., lupus erythematosus, rheumatoid arthritis, drug-related ITP, and Human Immunodeficiency Virus (HIV).\n3. Patients with Evans Syndrome.\n4. Patients known to be infected with hepatitis B virus, hepatitis C virus, or HIV.\n5. History of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction.\n6. Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to any of the excipients.\n7. Patient unresponsive previously to IVIg or anti-D Ig treatment.\n8. Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA.\n9. Splenectomy within 4 weeks of the Baseline Visit or planned splenectomy throughout the study period.\n10. Participants with known inherited thrombocytopenia. e.g., MYH-9 disorders.\n11. Participants with myelodysplastic syndrome (MDS).\n12. Administration of IVIg, anti-D immunoglobulin, Mercaptopurine, Vinca alkaloid, or platelet enhancing drugs (including thrombopoietin receptor agonists \\[TPO-RA\\], immunosuppressive, or other immunomodulatory drugs) within 3 weeks of the Baseline Visit, except for:\n\n    1. patients on a stable dose of TPO-RA within 4 weeks of the Baseline Visit\n    2. patients on a stable dose of Mycophenolate Mofetil within 3 months of the Baseline Visit\n    3. patients on stable dose of Danazol within 3 months of the Baseline Visit\n    4. long-term corticosteroid therapy for ITP, when the dose had been stable within 3 weeks of the Baseline Visit and no dosage change was planned until the EOS Visit\n    5. long-term azathioprine, cyclophosphamide, or attenuated androgen therapy when the dose had been stable within 3 months of the Baseline Visit, and no dosage change was planned until after study completion. Treatment with any other products licensed for primary chronic ITP is also exclusive. An appropriate wash-out period must be determined in case of patients who might be eligible for treatment with IVIg.\n13. Received any blood, blood product, or blood derivative within 1 month of the Baseline Visit.\n14. Received rituximab within 6 months of the Baseline Visit.\n15. Had a platelet transfusion or receipt of blood products containing platelets within 7 days of Visit 1 (Day 1).\n16. Received recombinant activated factor VII within 7 days of the Baseline Visit.\n17. Had therapy with live attenuated virus vaccines within 3 months of the Baseline Visit.\n18. Use of loop diuretics within 1 week of the Baseline Visit.\n19. Patients at high risk of thrombotic events.\n20. Uncontrolled hypertension \\[i.e., diastolic blood pressure \\>100 mmHg and\u002For systolic blood pressure \\>160 mmHg\\]. If a single measure exceeds this limit, a triple repeat measurement may be performed and the average of the three measurements used.\n21. Congestive heart failure as per New York Heart Association III\u002FIV, cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemic heart disease, hyperviscosity.\n22. Patients with significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia.\n23. Patients with hyperproteinemia, increased serum viscosity, and\u002For hyponatremia.\n24. Severe liver or kidney disease (normal reference ranges of laboratory doing the analysis):\n\n    1. alanine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5x \\> upper limit of normal (ULN)\n    2. creatinine \\> 120 μmol\u002FL\n    3. blood urea nitrogen (BUN) \\> 2.5x ULN\n25. Signs of severe anemia: Hemoglobin of less than 7 g\u002FdL, hemodynamically unstable due to active bleeding, and\u002For when evidence of end-organ ischemia secondary to severe anemia is present.\n26. Body mass index \\> 40 kg\u002Fm2 or an IVIg dose that puts the patient at risk of fluid overload.\n27. History of a malignant disease within 3 years of the Baseline Visit other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin.\n28. Patient has participated in an interventional, investigational clinical study within 30 days of the Baseline Visit or within 5 half-lives of the investigational medicinal product (IMP) under investigation.\n29. Any condition that the Investigator believes is likely to interfere with evaluation of the IMP or with satisfactory conduct of the trial.","70 Years",{"count":56,"type":20},40,[23],"The purpose of this study is to evaluate the efficacy and safety of KIg 10 (Intravenous Immunoglobulin 10%) in adult patients with chronic primary ITP",[60],"Chronic Primary Immune Thrombocytopenia (ITP)",[52,62,63,64,65,66],"Primary Immune Thrombocytopenia","Autoimmune Disease","Hemorrhagic Disorders","Hematologic Diseases","Blood Coagulation Disorders","2026-06-15",{"date":69,"type":37},"2026-06-16",{"date":71,"type":37},"2025-08-13",{"date":73,"type":20},"2026-08",{"name":43,"class":44},27,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100635461","phase-3-a-study-investigating-intravenous-human-normal-immune-globulin-10-in-adults-with-stiff-person-syndrome-100635461","NCT07552987","A Study Investigating Intravenous Human Normal Immune Globulin 10% in Adults With Stiff Person Syndrome","A Phase III, Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of Intravenous Human Normal Immune Globulin (IGIV) 10% in Adult Patients With Stiff Person Syndrome","Inclusion Criteria:\n\n1. Male or female, 18-70 years of age.\n2. Patient has signed the Informed Consent Form (ICF).\n3. Diagnosed with SPS per the following criteria:\n\n   a. Clinical symptoms (must have 1 of 2) i. Stiffness (axial regions, limbs, or both) ii. Episodic spasms (axial regions, limbs, or both) triggered by noises, tactile stimuli, emotional stress.\n\n   b. Clinical signs during symptomatic phase of illness (must have 1 of 3) i. Increased muscle tone (axial or limbs) ii. Exaggerated lumbar lordosis iii. Concurrent stiffness of lumbar paraspinal and abdominal muscles. c. Serological findings (must have 1 of 2), based on participant medical history: i. High-titer GAD65-IgG in the serum (e.g. ≥ 20 nmol\u002FL by radio-immunoprecipitation assay or 10,000 IU\u002FmL by enzyme-linked immunoassay \\[ELISA\\]) or any positive titer in cerebrospinal fluid \\[CSF\\] ii. Glycine-R-IgG in serum and\u002For CSF by live cell binding assay.\n4. Patients must have paravertebral stiffness and torso\u002Flower extremity predominance.\n5. Distribution of stiffness index score of ≥ 2, including stiffness in the legs or trunk.\n6. Patient may be Ig-naïve or Ig-pre-treated, however they should not have received Ig within 3 months prior to the time of study entry (Day 0).\n\n   1. Includes newly diagnosed patients\n   2. Includes patients who have received symptomatic treatments only\n   3. Includes patients who have failed to respond to rituximab.\n7. Patients who have received rituximab in the past 18 months must have B-cell reconstitution test results available from within 3 months prior to enrolment that confirms restoration of humoral immunity.\n8. Daily symptomatic therapy has been stable for a minimum of two weeks prior to screening and is expected to remain stable throughout the duration of the study.\n9. Willing to comply with all requirements of the protocol, including travel to site for scheduled protocol assessments and treatment, and completion of a diary for the study duration.\n10. For women of childbearing potential (WOCBP), a negative urine pregnancy test at screening, on enrollment (Day 0), and agreement to employ effective birth control measures during the study until the end of study (EOS) visit.\n11. Authorization to access personal health information.\n\nExclusion Criteria:\n\n1. Patients incapable of giving informed consent.\n2. Patients with SPS-plus or variants of SPS such as paraneoplastic or progressive encephalomyelitis with rigidity and myoclonus (PERM). Patients with pure cerebellar ataxia, ocular motor apraxia.\n3. Patients who are bed-bound or wheelchair-dependent.\n4. Ongoing\u002Factive infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV Type 1\u002F2 infection. Subjects with chronic hepatitis B or hepatitis C infection currently on treatment may participate if they have undetectable viral load within 12 months of screening date.\n5. Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to glycine (used as an excipient).\n6. Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA.\n7. Patients who are planning to receive the following treatments within the coming 12 months, or who have received in the stated timeframe before enrollment (Day 0)\n\n   1. Botulinum toxin within 6 months\n   2. Rituximab within 6 months\n   3. Steroid-sparing immunosuppressants (azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil) within 1 month\n   4. Plasmapheresis within 3 months.\n8. Prior chimeric antigen receptor (CAR)-T cell therapy or autologous hematopoietic stem-cell transplantation.\n9. Received any blood, blood product, or blood derivative within 1 month of the baseline visit.\n10. Had therapy with live attenuated virus vaccines within 3 months of the baseline visit.\n11. Use of loop diuretics within 1 week of the baseline visit.\n12. Patients at high-risk of thrombotic events such as deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction.\n13. Uncontrolled hypertension (i.e., diastolic blood pressure \\[BP\\] \\> 100 mmHg and\u002For systolic BP \\> 160 mmHg). If a single measure exceeds this limit, a triple repeat measurement may be performed and the average of the three measurements used.\n14. Congestive heart failure as per New York Heart Association III\u002FIV, cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemic heart disease, hyperviscosity.\n15. Patients with significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia.\n16. Patients with hyperproteinemia, increased serum viscosity, and\u002For hyponatremia.\n17. Severe liver or kidney disease (normal reference ranges of laboratory doing the analysis):\n\n    1. Alanine aminotransferase (ALT) or aspartate amino transferase (AST) \\>2.5x upper limit of normal (ULN)\n    2. Creatinine \\> 120 µmol\u002FL\n    3. Blood urea nitrogen (BUN) \\> 2.5x ULN.\n18. Signs of severe anemia: Hemoglobin of less than 7 g\u002FdL, hemodynamically unstable due to active bleeding, and\u002For when evidence of end-organ ischemia secondary to severe anemia is present.\n19. Body mass index \\> 35 kg\u002Fm2 or an IVIg dose that puts the patient at risk of fluid overload.\n20. History of a malignant disease within 3 years of the baseline visit other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin.\n21. Patients having participated in an interventional, investigational clinical study within 30 days of the baseline visit, or within 5 half-lives of the investigational medicinal product (IMP) under investigation.\n22. Any condition that the Investigator believes is likely to interfere with evaluation of the IMP or with satisfactory conduct of the trial.",{"count":84,"type":20},38,[23],"The purpose of this study is to evaluate the efficacy and safety of QIVIGY (Intravenous Human Normal Immune Globulin 10%) compared with placebo in adult participants with stiff person syndrome (SPS).",[88],"Stiff Person Syndrome",[88,90,91,63,30],"SPS","Neurological Disorders","NOT_YET_RECRUITING","2026-06-08",{"date":95,"type":37},"2026-06-10",{"date":97,"type":20},"2026-09",{"date":99,"type":20},"2028-07",{"name":43,"class":44},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":115,"locationsCount":4},"100407487","sponsor-initiated-expanded-access-protocol-intermediate-size-patient-population-100407487","NCT04586062","Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population","Inclusion Criteria:\n\n* Subjects diagnosed with LC associated with Type I plasminogen deficiency, confirmed by laboratory documentation at screening visit, with or without ocular pseudomembranes. The presence of membranes in different areas is not an exclusion criterion.\n* Subjects and their legally authorized representative, in the case of subjects \\\u003C18 years of age, should be informed of the nature of the treatment, agree to its provision, sign and date the informed and data handling consent forms approved by the IRB.\n* Subjects must be available for the duration of the treatment and agree to be compliant with the protocol visit and follow-up schedule.\n* Subjects agree to keep the treating physician or specialist in charge informed about any occurrence related to the treatment.\n\nExclusion Criteria:\n\n* Subjects with any condition which, in the opinion of the treating physician or specialist in charge might interfere with the treatment.\n* Females of childbearing potential who are either pregnant or not using an adequate method of birth control (adequate is defined as hormonal contraceptive or partner vasectomy for at least 3 months, condoms, intrauterine device \\[IUD\\], abstinence or other prescribed birth control). Enrolled males must agree to utilize appropriate contraceptive methods to prevent pregnancy in partners.\n* Females who are breastfeeding.","EXPANDED_ACCESS","The purpose of this protocol is to provide compassionate use of Kedrion Human Plasminogen Ophthalmologic Drops to an expanded population of patients diagnosed with ligneous conjunctivitis associated with type I Plasminogen deficiency until product licensure, and\u002For until a new clinical trial is available and the patients in treatment under Expanded Access are eligible to participate in the new trial.",[110],"Ligneous Conjunctivitis","AVAILABLE","2023-10-04",{"date":114,"type":37},"2023-10-05",{"name":43,"class":44},""]