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Anemia clinical trials

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NCT ID: NCT06254287 Not yet recruiting - Anemia, Aplastic Clinical Trials

Efficacy and Safety of Avatrombopag vs. Avatrombopag Combined With rhTPO in the Treatment of SAA

Start date: February 1, 2024
Phase: Phase 2
Study type: Interventional

Title: Efficacy and safety of Avatrombopag VS Avatrombopag combined with rhTPO in patients with severe aplastic anemia: a single-center, controlled study Observation group: Patients with severe aplastic anemia who did not respond to initial treatment (unconditional HSCT or ATG) or other treatments (except HSCT) Objective: To evaluate the efficacy and safety of Avatrombopag and rhTPO in the treatment of patients with severe aplastic anemia, to provide more treatment options for patients with severe aplastic anemia who are unable to undergo transplantation /ATG or have failed previous treatment, and to provide evidence-based evidence for the use of Avatrombopag or combined with rhTPO to promote hematopoietic recovery Experimental design: Single center, controlled study Total number of cases: 30 cases/group, 2 groups Case selection criteria: Inclusion criteria: 1. Age: > 18 years old, gender is not limited; 2. Patients clinically diagnosed with severe aplastic anemia (diagnostic criteria: ① myelocyte hyperplasia < 25% of normal; If ≥ 25% of normal but < 50%, the remaining hematopoietic cells should be < 30%. ② Blood routine must have two of the following three items: ANC < 0.5×109 /L; The absolute value of reticulocyte was < 20×109 /L; PLT < 20×109 /L). ③ If ANC < 0.2×109 /L, the diagnosis is very severe aplastic anemia), including patients who are newly diagnosed or have failed other treatments; 3. Patients currently undergoing hematopoietic stem cell transplantation or ATG without conditions; 4. Eastern Cancer Collaboration Group (ECOG) score 0-2; 5. Informed consent must be signed before participating in the study. Exclusion criteria: One of the following circumstances is not eligible for inclusion: 1. Patients with severe bleeding and/or infection that cannot be controlled after standard treatment; 2. Diagnosis of congenital hematopoietic failure (such as Fanconi anemia, congenital dyskeratosis, etc.); 3. Other causes of pancytopenia and bone marrow hypoproliferative diseases (such as hemolytic PNH, hypoproliferative MDS/AML, autoantibody-mediated pancytopenia, etc.); 4. All laboratory or clinically confirmed HIV infection, hepatitis C infection, chronic hepatitis B infection, or evidence of active hepatitis during screening; 5. Cytogenetic evidence of bone marrow abnormalities in clonal blood diseases; 6. History of thromboembolism or current use of anticoagulants within the past 6 months; 7. Accompanied by any one or more malignant diseases; 8. Treatment with another investigational agent within 30 days prior to the first dose of Avatrombopag; 9. Patients who cannot understand or are unwilling to sign an informed consent form (ICF); 10. Pregnant or lactating women; 11. The female patient or the female spouse of the male patient is unable to take effective contraceptive measures; 12. The Investigator considers that there are any other circumstances that may cause the subject to be unable to complete the study or that pose a significant risk to the subject. Exit criteria: 1. The subject or his legal guardian voluntarily requests withdrawal; 2. Violation of inclusion/exclusion criteria; 3. Poor medication compliance; 4. The subject's condition requires treatment with drugs prohibited by the study; 5. Adverse events occur that cause subjects to be unable to continue the study; 6. Other unexplained severe comorbidities; 7. Pregnancy occurs during treatment; 8. Subjects deemed unsuitable for further study by the investigator. Test termination: 1. For safety reasons, the study sponsor proposes to stop the study; 2. The Ethics committee decides to stop the study; 3. The lead researcher decides to stop the study. Investigational drug: Avatrombopag: tablet, specification: 20 mg/ tablet. rhTPO: 15000 units /1 ml. Treatment plan: This clinical trial is planned to carry out a 3-month drug study. A: The Avatrombopag group was given Avatrombopag: 40 mg/ time, once a day, orally, for 3 months. B: Avatrombopag +rhTPO group, Avatrombopag: 40 mg/ time, once a day, orally; rhTPO: 15000U/ time, once a day, subcutaneous injection; Both were 3 months. Efficacy index: Main therapeutic indicators: Overall response rate at 3 months (OR); Secondary efficacy measures: Complete response rate at 3 months (CR); The time of the first occurrence of PR and CR within 3 months of medication; The proportion of subjects who were off platelet transfusion at 3 months; Hemorrhage score records of patients within 3 months of medication; Health-related quality of life score (SF-36 scale). Efficacy criteria: Complete response (CR) : HGB > 100 g/L; ANC > 1.5 × 109 /L; PLT > 100×109/L; Partial response (PR) : disengagement from component blood transfusion and no longer meeting the diagnostic criteria for SAA; Invalid (NR) : SAA diagnostic criteria are still met.

NCT ID: NCT06248749 Not yet recruiting - Clinical trials for Anaemia in Ovarian Carcinoma

Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian Cancer

Start date: February 29, 2024
Phase: Phase 3
Study type: Interventional

Cancer related anemia (CRA) is a common sign occurring in more than 30% of patients at diagnosis, prior to initiation of antineoplastic therapy. Anemia is known to impact survival, disease progression, treatment efficacy, and the patient's quality of life. Proinflammatory cytokines, mainly IL-6, which are released by both tumor and immune cells, play a pivotal action in CRA etiopathogenesis: they promote alterations in erythroid progenitor proliferation, erythropoietin (EPO) production, survival of circulating erythrocytes, iron balance, redox status, and energy metabolism, all of which can lead to anemia. Chronic inflammatory conditions such as cancer influences a compromised nutritional status, which in-turn may contribute to anemia. This study aims to study the role of intravenous (IV) iron infusion in the management of anemia presented in patients previously treated or currently being treated for ovarian cancer. The study aims to identify the safety and efficacy of IV iron infusion on anemia in ovarian cancer patients, and the effect on quality of life and overall survival

NCT ID: NCT06245746 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

UCMSC-Exo for Chemotherapy-induced Myelosuppression in Acute Myeloid Leukemia

Start date: March 2024
Phase: Phase 1
Study type: Interventional

The purpose of the study is to explore the safety and efficacy of UCMSC-Exo in consolidation chemotherapy-induced myelosuppression in patients with acute myeloid leukemia after achieving complete remission.

NCT ID: NCT06240754 Not yet recruiting - Clinical trials for Clonal Cytopenia of Undetermined Significance

Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial

Start date: April 30, 2024
Phase: Phase 2
Study type: Interventional

Study researchers think that a drug called enasidenib may help people with clonal cytopenia of undetermined significance (CCUS) because the drug blocks the mutated IDH2 protein, which may improve blood cell counts. The purpose of this study is to find out whether enasidenib is a safe and effective treatment for CCUS.

NCT ID: NCT06234332 Not yet recruiting - Obesity Clinical Trials

Peking University Birth Cohort in Weifang (PKUBC-WF)

Start date: February 1, 2024
Phase:
Study type: Observational

The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces are also collected.

NCT ID: NCT06220461 Not yet recruiting - Extreme Prematurity Clinical Trials

Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants

FASCINATE
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Anemia of Prematurity (AOP) is very common in extremely preterm infants and often leads to blood transfusions. Folic acid, essential for growth and DNA synthesis, is deficient in premature infants. Despite the adoption of folic acid supplementation, evidence supporting its effectiveness in preventing AOP remains scarce. Recommendations for folic acid intake exceed what's naturally found in breast milk, particularly for extremely low birthweight infants. Practices regarding folic acid supplementation vary widely, prompting the need for research. The FACINATE trial aims to determine if additional folic acid supplementation improves hemoglobin levels and reduces late blood transfusions in extremely preterm infants, a question not addressed in current literature.

NCT ID: NCT06219395 Not yet recruiting - Clinical trials for Iron Deficiency Anemia

Capsule Endoscopy in Iron Deficiency Anaemia

WCE-IDA
Start date: March 1, 2024
Phase:
Study type: Observational

This project aim to investigate whether wireless capsule endoscopy(WCE) has a similar diagnostic yield as conventional endoscopy in detecting the cause of iron deficiency anemia (IDA)

NCT ID: NCT06210295 Not yet recruiting - Clinical trials for Refractory Anemia in Systemic Lupus Erythematosis

Anemia in Systemic Lupus Erythematosus Specially Refractory Type

Start date: March 9, 2024
Phase:
Study type: Observational

Systemic lupus erythroematosis (SLE) is a systemic autoimmune disease with multisystemic involvement. The condition has several phenotypes, with varying clinical presentations from mild mucocutaneous manifestations to multiorgan and severe central nervous system involvement. Several immunopathogenic pathways play a role in the development of SLE. Despite recent advances in technology and understanding of the pathological basis and risk factors for SLE, the exact pathogenesis is still not well known. Diagnosis of SLE can be challenging, and while several classification criteria have been posed, their utility in the clinical setting is still a matter of debate. Management of SLE is dictated by organ system involvement. Despite several agents shown to be efficacious in treating SLE, the disease still poses significant morbidity and mortality risks in patients[1]. Haematological abnormalities are common in systemic lupus erythroematosis. Anemia is found in about 50% of patients.

NCT ID: NCT06198790 Not yet recruiting - Anemia Clinical Trials

Postoperative Anemia After Bariatric Surgery

Start date: February 1, 2024
Phase:
Study type: Observational [Patient Registry]

To investigate the real incidence of short and long-term anemia after bariatric surgery, and explore the risk factors.

NCT ID: NCT06176430 Not yet recruiting - Cerebral Palsy Clinical Trials

Comparison of Twice Weekly Versus Daily Iron Therapy in Treating Anemia in Children With Cerebral Palsy

Start date: February 1, 2024
Phase: Phase 4
Study type: Interventional

a randomized clinical trial to compare the effect of twice weekly versus daily iron therapy in treating anemia in children with cerebral palsy, to be conducted at Department of pediatric medicine children's hospital PIMS islamabad.