[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transfusion-dependent-anemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transfusion-dependent-anemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100547904","phase-3-tranexamic-acid-for-reduction-of-transfusion-in-abdominal-surgery-100547904",false,"NCT06414031","Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery","Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled Trial","TATRA","Inclusion Criteria:\n\n1. Age 18 years or above\n2. Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy\n3. Adequate renal function with serum creatinine \\\u003C250 µmol\u002FL (2.82 mg\u002FdL)\n4. Written informed consent obtained before randomization\n5. Negative pregnancy test for women of childbearing potential within 14 days of commencing study treatment. Females of reproductive potential must agree to practice highly effective contraceptive measures during the study. These comprise measures with a failure rate of \\\u003C1% per year when used consistently and correctly, such as intravaginal and transdermal combined (oestrogen and progestogen containing) hormonal contraception, injectable and implantable progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period).\n\nExclusion Criteria:\n\n1. Severe anaemia, defined as a haemoglobin concentration \\\u003C8 g\u002FdL (\\\u003C5 mmol\u002FL) or anaemia with haemoglobin concentration ≥8 to \\\u003C10 g\u002FdL (≥5,0 to \\\u003C6,2 mmol\u002Fl) and one or several of the following symptoms suggesting hypoxemia:\n\n   * Clinical signs of tachycardia, e.g., resting heart rate \\>100 beats\u002Fminute, palpitation etc.\n   * Clinical signs of hypotension, e.g., resting systolic blood pressure \\\u003C100 mmHg, orthostatic dysregulation etc.\n   * Clinical signs of dyspnea, e.g., speech dyspnea, resting respiratory rate \\>20 breaths\u002Fmin.\n2. Thrombocytopenia with platelets \\\u003C60 x 109 \u002FL\n3. Confirmed bleeding disorder with the need for specific preventive perioperative treatment (e.g., factor deficiency with the need of perioperative substitution)\n4. A priori refusal of blood transfusions\n5. Confirmed thrombophilia with a pertinent need for perioperative anticoagulation\n6. Allergy \u002F hypersensitivity to tranexamic acid\n7. Recent (\\\u003C30 days) thromboembolic event\n8. History of medically confirmed convulsions\n9. In female subjects: pregnancy or lactation","ALL","18 Years",{"count":20,"type":21},850,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this clinical trial is to learn if the administration of tranexamic acid can reduce the necessity of blood transfusions in adult patients undergoing major abdominal surgery. . It will also inform about safety of tranexamic acid in this setting.\n\nThe main question it aims to answer is: Does tranexamic acid lower the probability of receiving at least one blood transfusion during or after surgery?\n\nParticipants will compare tranexamic acid o a placebo (a look-alike substance that contains no drug) to see if tranexamic acid works to reduce the necessity of a blood transfusion.",[27,28,29],"Surgical Blood Loss","Transfusion-dependent Anemia","Abdomen Disease","RECRUITING","2026-04-28",{"date":33,"type":34},"2026-04-29","ACTUAL",{"date":36,"type":34},"2024-06-17",{"date":38,"type":21},"2026-11-30",{"name":40,"class":41},"Ulrich Ronellenfitsch, MD","OTHER",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100510258","phase-2-efficacy-and-safety-of-luspatercept-for-the-treatment-of-anemia-due-to-mds-with-del5q-refractoryresistantintolerant-to-prior-treatments-rbc-td-100510258","NCT05924100","Efficacy and Safety of Luspatercept for the Treatment of Anemia Due to MDS With del5q, Refractory\u002FResistant\u002FIntolerant to Prior Treatments, RBC-TD","Efficacy and Safety of Luspatercept for the Treatment of Anemia Due to Myelodysplastic Syndromes With del5q, Refractory\u002FResistant\u002FIntolerant to Prior Treatments, Who Require Red Blood Cell Transfusions","Phoenix","Inclusion Criteria:\n\n1. Subject must understand and voluntarily sign an ICF prior to any study-related assessments\u002Fprocedures being conducted.\n2. Documented diagnosis of MDS with del5q according to 2018 WHO classification\n3. IPSS-R classification (Greenberg, 2012) of very low, low, or intermediate risk disease, and:\n\n   * \\\u003C 5% blasts in bone marrow\n   * Peripheral blood WBC count \\\u003C13,000\u002FμL\n4. Refractory or intolerant to, or ineligible for, prior ESA treatment\n5. If previously treated with ESAs or granulocyte colony-stimulating factor (G-CSF), both agents must have been discontinued ≥ 4 weeks prior to date of screening.\n6. Refractory or intolerant to, or ineligible for, prior lenalidomide treatment, as defined by any one of the following:\n\n   * Refractory to prior lenalidomide treatment for at least 4 cycles; - documentation of non-response or response that is no longer maintained (HI-E)\n   * Intolerant to prior lenalidomide treatment - documentation of discontinuation of lenalidomide at any time after introduction due to intolerance or an adverse event\n   * lenalidomide ineligible -platelet counts below 50000\u002Fmmc or absolute neutrophil count below 500\u002Fmmc at the start of treatment\n   * lenalidomide must have been discontinued ≥ 4 weeks prior to date of screening.\n\n   Requires RBC transfusions, as documented by the following criteria:\n   * average transfusion requirement of ≥ 2 units\u002F8 weeks of pRBCs confirmed for a minimum of 16 weeks immediately preceding enrolment.\n   * Hb levels at the time of or within 7 days prior to administration of a RBC transfusion must have been ≤ 10.0 g\u002FdL in order for the transfusion to be counted towards meeting eligibility criteria. RBC transfusions administered when Hb levels were \\> 10.0 g\u002FdL and\u002For RBC transfusions administered for elective surgery will not qualify as a required transfusion for the purpose of meeting eligibility criteria.\n   * no consecutive 56-day period that was RBC transfusion-free during the 16 weeks immediately preceding screening\n7. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2\n8. Females of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months), must:\n\n   * Have two negative pregnancy tests as verified by the Investigator prior to starting study therapy (unless the screening pregnancy test was done within 72 hours of C1D1). Refer to Section 6.1 for additional details. She must agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment.\n   * If sexually active, agree to use, and be able to comply with, highly effective contraception without interruption, 5 weeks prior to starting investigational product, during the study therapy (including dose interruptions), and for 12 weeks after discontinuation of study therapy.\n9. Male subjects must:\n\n   * Agree to use a condom, defined as a male latex condom or non latex condom not made out of natural (animal) membrane (for example, polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 12 weeks following investigational product discontinuation, even if he has undergone a successful vasectomy.\n10. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n1. P53 mutation at screening\n2. Prior therapy with disease modifying agents for underlying MDS disease (hypomethylating agents)\n\n   * subjects who previously received HMA may be enrolled at the investigator's discretion contingent that the subject received no more than 1 dose of HMA). The last dose must be ≥ 5 weeks from the date of screening.\n3. Previously treated with either luspatercept (ACE-536) or sotatercept (ACE-011)\n4. Secondary MDS, ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and\u002For radiation for other diseases. 5 Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding\n\n6\\. Prior allogeneic or autologous stem cell transplant 7. Known history of diagnosis of AML 8. Use of any of the following within 5 weeks prior to study entry:\n\n* anticancer cytotoxic chemotherapeutic agent or treatment\n* corticosteroid, except for subjects on a stable or decreasing dose for ≥ 1 week prior to study entry for medical conditions other than MDS\n* iron-chelating agents, except for subjects on a stable or decreasing dose for at least 8 weeks prior to screening\n* other RBC hematopoietic growth factors\n* investigational drug or device, or approved therapy for investigational use. If the half- life of the previous investigational product is known, use within 5 times the half- life prior to screening or within 5 weeks, whichever is longer is excluded. 9. Uncontrolled hypertension, defined as repeated elevations of diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment. 10. Estimated glomerular filtration rate (eGFR) or creatinine clearance \\\u003C 40 mL\u002Fmin.\n\n  11\\. Serum aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase or alanine aminotransferase\u002Fserum glutamic pyruvic transaminase ≥ 3.0 x upper limit of normal (ULN) 12. Total bilirubin ≥ 2.0 x ULN.\n* higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (ie, ineffective erythropoiesis) or in the presence of known history of Gilbert Syndrome.\n* subjects are excluded if there is evidence of autoimmune hemolytic anemia 13. Prior history of malignancies, other than MDS, unless the subject has been free of the disease (including completion of any active or adjuvant treatment for prior malignancy) for ≥ 5 years. However, subjects with the following history\u002Fconcurrent conditions are allowed:\n* Basal or squamous cell carcinoma of the skin\n* Carcinoma in situ of the cervix\n* Carcinoma in situ of the breast\n* Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis \\[TNM\\] clinical staging system)",{"count":52,"type":21},22,[54],"PHASE2","Myelodysplastic syndromes, primarily affecting older adults, are a heterogeneous group of clonal disorders of hematopoietic stem cells characterized by ineffective hematopoiesis that manifest clinically as anemia, neutropenia, and\u002For thrombocytopenia of variable severity; these often result in RBC- transfusion dependent (TD) anemia, increased risk of infection, and\u002For hemorrhage, as well as a potential to progress to acute myeloid leukemia (AML).\n\nLenalidomide is approved for red blood cell transfusion-dependent (RBC TD) anemia due to low-risk myelodysplastic syndromes (MDS) with a chromosome 5q deletion (del5q) with or without additional cytogenetic abnormalities. About one third of patients are refractory\u002Fresistant\u002Fintolerant and will require further treatment options.\n\nLuspatercept (ACE-536), an erythroid maturation agent, is a recombinant fusion protein consisting of a modified form of the extracellular domain (ECD) of the human activin receptor type IIB (ActRIIB) linked to the Fc portion of human immunoglobulin G1 (IgG1-Fc). Luspatercept acts on endogenous inhibitors of late-stage erythropoiesis (eg, growth differentiation factor 11, GDF11) to increase release of mature erythrocytes into circulation. Nonclinical data have demonstrated that luspatercept binds to negative regulators governing late-stage erythroid development to inhibit their action, thereby promoting the maturation of erythrocytes in the bone marrow.\n\nLuspatercept is indicated for the treatment of adult patients with transfusion-dependent anaemia associated with beta-thalassaemia and due to very low, low and intermediate-risk MDS with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based-therapy. It is not indicated for other MDS subtypes. Unfortunately, patients with MDS with del5q refractory\u002Fresistant\u002Fintolerant to lenalidomide are excluded from clinical trials that evaluate novel treatments for the anemia of RBC TD lower risk MDS. Therefore, treatment of anemia in such patients is an unmet need.\n\nQOL-ONE Phoenix is a Phase 2, multicenter, single arm, prospective study. The primary objective of the study is to evaluate the effect of luspatercept on RBC TI in subjects with MDS with del5q with IPSS-R very low, low, or intermediate risk and \\\u003C 5% bone marrow blasts, resistant\u002Frefractory\u002Fintolerant to lenalidomide and who require RBC transfusions.\n\nThe study is divided into a Screening Period, a 2-year Treatment Period and a 3-year Follow-up Period.\n\nPrimary objective is to evaluate the effect of luspatercept on RBC TI (lack of transfusions for 8 consecutive weeks within the first 24 weeks) in subjects with MDS with del5q with IPSS-R very low, low, or intermediate risk and \\\u003C 5% bone marrow blasts, resistant\u002Frefractory\u002Fintolerant to lenalidomide and RBC TD.",[57,58,59,28],"Myelodysplastic Syndromes","Del(5Q)","Anemia",[61],"MDS with Del(5Q)","2024-11-14",{"date":64,"type":34},"2024-11-18",{"date":66,"type":34},"2022-11-03",{"date":68,"type":21},"2029-12-03",{"name":70,"class":41},"Associazione Qol-one",23,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100556503","phase-4-efficacy-and-safety-of-rhtpo-in-combination-with-cyclosporine-versus-cyclosporine-alone-in-the-treatment-of-td-nsaa-100556503","NCT06525948","Efficacy and Safety of rhTPO in Combination With Cyclosporine Versus Cyclosporine Alone in the Treatment of TD-NSAA","Efficacy and Safety of rhTPO in Combination With Cyclosporine Versus Cyclosporine Alone in the Treatment of Transfusion-dependent Non-severe Aplastic Anaemia (TD-NSAA)","Inclusion Criteria:\n\n1\\. aged ≥ 18 years, male and female; 2. patients with a clear diagnosis of NSAA who are dependent on transfusion therapy:\n\n1. Meet the Camitta NSAA criteria;\n2. accompanied by at least one of the following abnormalities: (1) dependence on component blood transfusion therapy, at least one component blood transfusion every 8 weeks on average, and the duration of transfusion dependence ≥ 4 months, the indication of component blood transfusion: HGB ≤ 60g \u002F L; (2) PLT ≤ 10 × 10 \\^ 9 \u002F L, or PLT ≤ 30 × 10 \\^ 9 \u002F L with a significant tendency to bleed; (3) neutrophils ≤ 0.5 × 10 \\^ 9 \u002F L.\n3. Excluding other haematological and non-haematological diseases that cause pancytopenia; 3. ECOG PS score 0-2, expected survival ≥ 3 months with follow-up; 4. functional levels of major organs must meet the following requirements: 1) Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); 2) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN; 3) blood creatinine (Cr) ≤ 1.5 x ULN; 5. has not been treated with platelet receptor agonist (TPO-RA) analogues and other immunosuppressant analogues; 6. the subject is not suitable or willing to receive haematopoietic stem cell transplantation therapy; 7. no history of serious heart, lung, liver, kidney and other important organs and endocrine system diseases; 8. Voluntarily enroll in the study, sign the informed consent, have good compliance and willing to cooperate with the follow-up.\n\nExclusion Criteria:\n\n1. have used other clinical investigational drugs within 4 weeks;\n2. a history of primary myelodysplastic syndromes (MDS), primary paroxysmal sleep haemoglobinuria (PNH) and leukaemia, as well as congenital bone marrow failure syndromes (IBMFS), such as Fanconi's anaemia (FA) and congenital dyskeratosis (DC)\n3. history of cirrhosis or history of portal hypertension;\n4. congestive heart failure, arrhythmia, peripheral arteriovenous thrombosis requiring medication within 1 year prior to enrolment, or myocardial infarction or cerebral infarction within 3 months prior to enrolment;\n5. HIV infection;\n6. severe autoimmune disease or immunodeficiency disease;\n7. suffering from malignant tumour\n8. severe mental disorders;\n9. a known history of allergy to the drug components of this regimen;\n10. in the opinion of the investigator, it is not appropriate to participate in this trial, e.g., any other medical, social or psychological factors that may affect safety or compliance with the study procedures.\n\nCompliance with study procedures.",{"count":80,"type":21},54,[82],"PHASE4","Investigating the efficacy and safety of rhTPO in combination with cyclosporine versus cyclosporine alone for the treatment of TD-NSAA",[85,28],"Aplastic Anemia","NOT_YET_RECRUITING","2024-07-26",{"date":89,"type":34},"2024-07-29",{"date":91,"type":21},"2024-07-30",{"date":93,"type":21},"2025-12-30",{"name":95,"class":41},"Peking Union Medical College Hospital",1]