[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Grifols Therapeutics LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":135},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,62,89,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100053904","phase-3-a-non-inferiority-pharmacokinetic-and-safetytolerability-study-of-two-different-doses-of-weekly-sc-alpha1-pi-15-compared-with-corresponding-standard-iv-alpha1-pi-in-participants-with-alpha1-antitrypsin-deficiency-aatd-100053904",false,"NCT07555483","A Non-inferiority Pharmacokinetic and Safety\u002FTolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)","An Open-Label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety\u002FTolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients With Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg\u002Fkg\u002FWeek and 120 mg\u002Fkg\u002FWeek Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)","SWIFT-SC","Inclusion Criteria:\n\n* Have a diagnosis of congenital AATD with an allelic combination of ZZ, SZ, Z(null), (null)(null), S(null), or \"at-risk\" alleles (patients with \"at-risk\" alleles must be individually evaluated for eligibility by the Medical Monitor). If the genotype has yet to be documented, a blood draw for genotyping (i.e., allelic discrimination) and phenotyping will be obtained at the Screening Visit.\n* Participants may be naïve to alpha1-PI augmentation therapy or may be currently receiving alpha1-PI augmentation therapy or received alpha1-PI augmentation therapy in the past. If the total alpha1-PI serum (alpha-1 antitrypsin \\[AAT\\]) level has yet to be documented as in a treatment-naïve patient, a blood draw for total alpha1-PI serum level will be obtained at the Screening Visit. For participants currently receiving alpha1-PI augmentation, a pre-alpha1-PI augmentation AAT level must be documented in the participant's medical history\u002Frecords.\n* All participants must have a documented total alpha1-PI serum level \\\u003C11 μM (80mg\u002FdL if measured by radial immunodiffusion or 50 mg\u002FdL if measured by nephelometry) which is documented pre-alpha1-PI augmentation for participants receiving AAT augmentation.\n* At the Screening Visit, have post-bronchodilator Forced Expiratory Volume in 1 second (FEV₁) ≥25% and \\\u003C80% predicted of predicted FEV₁\u002FForced Vital Capacity (FVC) \\\u003C70% (Global Initiative for Chronic Obstructive Lung Disease \\[GOLD\\] stage II-III, and some individuals are GOLD stage IV).\n* If the participant has received alpha1-PI augmentation therapy of any kind, he\u002Fshe must be willing to discontinue that treatment at the Week 1 (Baseline) Visit and remain off any kind of alpha1-PI treatment, other than the IPs of this study, while participating in the study.\n* Willing and able to provide written informed consent indicating that they understand the purpose of, and procedures required for the study and are willing to participate in it.\n\nExclusion Criteria:\n\n* Have had a moderate or severe chronic obstructive pulmonary disease (COPD) exacerbation during the 4 weeks before the Week 1 (Baseline) Visit.\n* Have history of lung or liver transplant or on transplantation waiting list.\n* Have any lung surgery during the past 1 year (excluding lung biopsy).\n* At screening, have elevated liver enzymes (aspartate aminotransferase \\[AST\\], alanine aminotransferase \\[ALT\\], and alkaline phosphatase \\[ALP\\]) ≥ 2.5 times the upper limit of normal (ULN).\n* Have severe concomitant disease (e.g., congestive heart failure, clinically significant pulmonary fibrosis, malignant disease \\[except for skin cancers other than melanoma\\], history of acute hypersensitivity pneumonitis reaction, or current chronic hypersensitivity pneumonitis).\n* Females who are pregnant, breastfeeding or, if of child-bearing potential†, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), condom or occlusive cap with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, male sterilization, or true abstinence\\*) throughout the study. †Women of childbearing potential are defined as premenopausal and not surgically sterile, post tubal ligation, nor documented as infertile due to a concurrent medical condition.\n\n  \\*True abstinence: When this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\], declaration of abstinence for the duration of a study, and withdrawal are not acceptable methods of contraception.)\n* Have known previous infection with or clinical signs and symptoms consistent with current Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) infection.\n* Have smoked during the past 6 months (this includes electronic\u002Fvapor cigarettes) or a positive urine cotinine test at the Screening Visit that is due to smoking.\n* Received IP in another study within 30 days prior to the Week 1 (Baseline) Visit or received any recombinant human AAT-Fc fusion protein (e.g., INBRX-101) or other extended half-life AAT products within 5 half-lives of the product relative to the Screening Visit date.\n* Have history of anaphylaxis or severe systemic response to any plasma-derived alpha1- PI preparation or other blood product(s).\n* Use systemic steroids above a stable dose equivalent to 5 mg\u002Fday prednisone (i.e., 10 mg every 2 days) within the 4 weeks prior to the Week 1 (Baseline) Visit (Note: inhaled steroids are not considered systemic steroids). It is recommended to maintain the same dose throughout the study.\n* Use systemic or aerosolized antibiotics for a COPD exacerbation within the 4 weeks prior to the Week 1 (Baseline) Visit.\n* Have known selective or severe Immunoglobulin A (IgA) deficiency based on prior medical records.\n* In the opinion of the Investigator, the participant may have compliance problems or any medical condition that may place them at safety risk with the protocol and the procedures of the protocol, or because of unstable health be unable to come to the study site for in-person clinic visits required by the protocol.","ALL","18 Years","80 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein.\n\nAdults with Alpha-1 Antitrypsin Deficiency will take part. Participants will be randomly assigned to one of the treatment groups, and both the study doctors and participants will know which treatment is being given.\n\nThe main goals of the study are to understand how the body processes the medicine (pharmacokinetics) and to assess how safe and well tolerated the different weekly doses are.",[28],"Alpha 1 Antitrypsin Deficiency",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48],"Phase 3","Clinical Trial","Alpha1-Proteinase Inhibitor (Human)","Alpha 1-Antitrypsin","Subcutaneous","Intravenous","Pulmonary Emphysema","Emphysema","Pathologic Processes","Pulmonary Disease, Chronic Obstructive","Lung Diseases, Obstructive","Lung Diseases","Respiratory Tract Diseases","Genetic Diseases, Inborn","Subcutaneous Emphysema","Serine Proteinase Inhibitors","Protease Inhibitors","Enzyme Inhibition","Molecular Mechanisms of Pharmacological Action","RECRUITING","2026-07-10",{"date":52,"type":53},"2026-07-13","ACTUAL",{"date":55,"type":53},"2026-05-05",{"date":57,"type":22},"2027-09-30",{"name":59,"class":60},"Grifols Therapeutics LLC","INDUSTRY",22,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":71,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100634479","phase-3-a-study-to-evaluate-the-pharmacokinetics-and-safety-of-xembify-versus-gamunex-c-in-participants-with-chronic-inflammatory-demyelinating-polyradiculoneuropathy-100634479","NCT07540221","A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy","An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy","XPERT","Inclusion Criteria:\n\n* Have typical CIDP or a CIDP variant according to the 2021 criteria established by the European Academy of Neurology\u002FPeripheral Nerve Society (EAN\u002FPNS). The level of diagnostic certainty may be CIDP or possible CIDP.\n* Participants ≤ 90 kg in body weight and requiring an IGIV dose equivalent to 0.3-1.0 g\u002Fkg every three weeks (Q3W) inclusive and between 20-90 g of IGIV Q3W inclusive.\n* Clinically stable on IGIV, defined as no recent change in CIDP treatment or experienced a CIDP relapse requiring treatment, within 12 weeks prior to Screening and through baseline visit.\n\nExclusion Criteria:\n\n* Diagnosis of polyneuropathy of any other cause (including multifocal motor neuropathy; monoclonal gammopathy of uncertain significance with anti-myelin-associated glycoprotein IgM antibodies; hereditary demyelinating neuropathy; polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes syndrome; lumbosacral radiculoplexus neuropathy; polyneuropathy associated with diabetes mellitus; polyneuropathy associated with systemic illnesses; or drug or toxin induced polyneuropathy).\n* Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study such as the following:\n\n  1. current malignancy or history of allogeneic bone marrow\u002Fstem cell transplant,\n  2. cardiac insufficiency (New York Heart Association classes III\u002FIV), cardiomyopathy, significant cardiac arrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension\n  3. chronic kidney disease stage IV or V\n  4. an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000\u002FµL \\[1.0 × 10\\^9\u002FL\\]), or human immunodeficiency virus (HIV) infection\u002Facquired immune deficiency syndrome\n  5. known bleeding disorders\n  6. severe skin disease at the planned injection sites\n  7. alcohol, drug or medication abuse, or\n  8. other disorders where IGSC therapy would be contraindicated during the study.\n* History of a thrombotic episode (including deep vein thrombosis, known hypercoagulable state, myocardial infarction, pulmonary embolism, or thromboembolic stroke)\n* Known allergic or other severe adverse reactions to blood products including intolerability to previous IVIG up to 1 g\u002Fkg Q3W, history of hemolysis after IVIG infusion, aseptic meningitis, recurrent severe headache, hypersensitivity, or severe generalized skin reaction\n* Has had a CIDP relapse requiring treatment modification within 12 weeks prior to Screening or between Screening and baseline visit\n* Treatment with any of the following:\n\n  1. alemtuzumab or rituximab within 12 months of Screening.\n  2. cyclophosphamide, interferon, tumor necrosis factor-alpha inhibitors, fingolimod, or fragment crystallizable receptor (FCRn) blockers, within six months of Screening\n  3. plasma exchange or complement inhibitors within three months of Screening.\n  4. changes to the following treatment within three months of Screening: methotrexate, azathioprine, or mycophenolate or any other immunosuppressants within six months of Screening\n  5. participants on corticosteroids ≥ 20 mg\u002Fday prednisone equivalent. Participants on low dose corticosteroids (\\\u003C 20 mg\u002Fday prednisone equivalent) may be enrolled if dose has been stable over the last three months prior to Screening and the dosage is not likely to be adjusted during the duration of the trial (inhaled or topical corticosteroids are allowed).\n* Participants requiring an IGIV dose equivalent to:\n\n  1. greater than 1.0 g\u002Fkg every three weeks (Q3W) or\n  2. less than 0.3 g\u002Fkg Q3W or\n  3. greater than 90 g of IGIV Q3W or\n  4. less than 20 g of IGIV Q3W.\n* Known IgA deficient patients with known antibodies against IgA\n* Known significant proteinuria (≥ 3+ or known urinary protein loss \\>1 g\u002F24 hours or nephrotic syndrome), acute renal failure, are on dialysis, and\u002For have severe renal impairment on Screening laboratory testing (blood urea nitrogen \\[BUN\\] \\> 3 times the upper limit of normal \\[ULN\\] or creatinine more than 1.5 times ULN).\n* Screening values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding ≥ 2.5 times the ULN for the expected normal range for the testing laboratory.\n* Hemoglobin levels \\\u003C 10 g\u002FdL at Screening.\n* Current administration of anti-coagulation therapy which would make IGSC administration inadvisable per investigator judgement (i.e., vitamin K antagonists, nonvitamin K antagonist oral anticoagulants \\[e.g., dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa\\], and parenteral anticoagulants \\[e.g., fondaparinux\\]).\n* Known hyperviscosity syndrome.\n* Known HIV, chronic hepatitis B virus (HBV), or chronic hepatitis C virus (HCV) infection.\n* Participation in another clinical trial within 30 days or if known, 5 half-lives of the interventional product prior to Screening (observational studies without investigative treatments \\[non-interventional\\] are permitted).",{"count":21,"type":22},[25],"The main goal of the study is to find out whether XEMBIFY, given once a week under the skin, provides similar levels of immunoglobulin G in the blood over time as Gamunex-C, which is given into a vein once every 3 weeks in people with CIDP.\n\nParticipants with CIDP will first have up to 28 days of screening to make sure they can join the study. Those who qualify will then start a 19-week treatment period with Gamunex-C. During this period, they will receive Gamunex-C through a vein once every 3 weeks, for a total of 7 doses. Approximately, one week after their last Gamunex-C dose, they will begin a 16-week treatment period with XEMBIFY under the skin, once a week for a total of 16 doses. Blood samples will be collected during both treatment periods to measure IgG level in the blood.",[74],"CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)",[76,77,78,79],"XEMBIFY","CIDP","IgG","Gamunex-C","2026-06-22",{"date":82,"type":53},"2026-06-24",{"date":84,"type":53},"2026-04-02",{"date":86,"type":22},"2027-12-31",{"name":59,"class":60},6,{"id":90,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":26,"conditions":93,"keywords":94,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":99,"leadSponsor":100,"locationsCount":101},"100635653",{"count":21,"type":22},[25],[28],[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48],"2026-05-28",{"date":97,"type":53},"2026-06-01",{"date":55,"type":53},{"date":57,"type":22},{"name":59,"class":60},19,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":120,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100488822","phase-3-a-study-to-evaluate-efficacy-safety-and-pk-of-xembifystandard-medical-treatment-smt-compared-to-placebosmt-to-prevent-infections-in-participants-with-hgg-and-recurrent-or-severe-infections-associated-with-b-cell-chronic-lymphocytic-leukemia-multiple-myeloma-and-non-hodgkin-lymphoma-100488822","NCT05645107","A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","EXCELL","Inclusion Criteria:\n\n* Participants ≥18 years of age at screening visit\n* Participants with documented and confirmed diagnosis of any of the below diseases:\n\n  * B-cell CLL according to International Workshop on CLL (iwCLL) criteria and RAI staging of intermediate (1 and 2) or high (3 and 4)\n  * MM according to the International Myeloma Working Group criteria (IMWG), R-ISS stage II or, III; or\n  * Histologically confirmed diagnosis of B-Cell NHL, Stage III or above (IV, Progressive\u002Frefractory, or recurrent\u002Frelapsed stage) according to the Lugano Classification.\n* Participants with HGG with IgG levels less than 5 g\u002FL. (Note: For MM subjects, the IgG level is adjusted by subtracting the M-protein \\[Mspike\\] to reflect the true polyclonal IgG concentration.)\n* Participants with documented history of at least one severe bacterial infection (bacterial or viral) or recurrent bacterial\u002Fviral infections (that is., ≥ 3 infections) within 12 months before the screening visit. Severe bacterial\u002Fviral infections ≥ Grade 3 (as defined by Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grades).\n\nExclusion Criteria:\n\n* Participants with documented history of hematopoietic stem cell transplant (allogenic transplant in the previous 24 months, and autologous transplant in the previous 3 months) before Screening visit.\n* Participants currently receiving immunoglobulin replacement therapy (IgRT) or have received IgG replacement treatment (i.e., prior immune globulin replacement therapy) within 6 months before the screening visit.\n* Participants with active infections at time of screening visit. Specific supportive anti-infective prophylactic defined in the CLL National Comprehensive Cancer Network (NCCN) or iwCLL guidelines and\u002For local\u002Finternational guidelines for the CLL, and defined in local\u002Finternational guidelines for MM and NHL are allowed, or recommended in the updated labelling of specific active target disease medicines used during the participation in the trial is also allowed.\n* Participants with active second malignancies.\n* Participants with known primary immunodeficiency (PI).\n* Participants with a life expectancy less than 1.5 years.\n* Participants with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the subject at undue medical risk.\n* Participants have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product.\n* Participants have a history of blistering skin disease, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study based upon the Investigator's discretion.\n* Participants have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement).\n* Participants with severe known kidney disease \\[as defined by estimated glomerular filtration rate \\[eGFR\\] less than (\\<) 30 milliliter (mL)\u002Fmin\u002F1.73 square meter (m2)\\] as determined by the Principal Investigator.\n* Participants that have liver enzyme levels (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], gammaglutamyl transferase \\[GGT\\], or lactate dehydrogenase \\[LDH\\]) greater than 3 times the upper limit of normal (ULN) at the Screening Visit as defined by the testing laboratory.\n* Participants have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (example, myocardial infarction, cerebrovascular accident, or transient ischemic attack) or deep venous thrombosis.\n* Participants currently have a known hyperviscosity syndrome or hypercoagulable states.\n* Participants have a known previous infection or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection.\n* Participants with non-controlled arterial hypertension (systolic blood pressure \\[SBP\\] greater than 140 millimeters of mercury (mmHg) and\u002For diastolic blood pressure \\[DBP\\] greater than 90 mmHg), and\u002For a heart rate (HR) greater than100 bpm.\n* Participants with known substance or prescription drug abuse within 12 months before the Screening Visit.\n* Participants have participated in another clinical trial within 30 days prior to screening (observational studies without investigative treatments \\[non-interventional\\] are permitted).",{"count":111,"type":22},386,[25],"The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.",[115,116,117,118,119],"Hypogammaglobulinemia","Bacterial Infections","B-cell Chronic Lymphocytic Leukemia","Multiple Myleoma","Non-Hodgkin Lymphoma",[76,121,122,123,124,125],"CLL","SMT","Hypogammaglobulinemia (HGG)","MM","NHL","2026-04-08",{"date":128,"type":53},"2026-04-13",{"date":130,"type":53},"2022-12-26",{"date":132,"type":22},"2026-06",{"name":59,"class":60},62,""]