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Purpura, Thrombocytopenic clinical trials

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NCT ID: NCT05262881 Not yet recruiting - Clinical trials for Thrombotic Thrombocytopenic Purpura, Acquired

A Retrospective, Observational Study on the Response to Caplacizumab Treatment in aTTP Patients: the Italian Experience (ROSCAPLI)

ROSCAPLI
Start date: March 1, 2022
Phase:
Study type: Observational

This study is a multicenter, retrospective, observational study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) treated with plasma exchange (PEX) in association with caplacizumab, and immunosuppression between Q4-2019 and 28 February2021. The retrospective study will measure: Age, sex, BMI, blood pressure at diagnosis, Platelet count at diagnosis and at the follow up visits, Hb level at diagnosis at the follow up visits, White blood cell count at diagnosis at the follow up visits, Creatinine at diagnosis at the follow up visits, schistocytes count at diagnosis at the follow up visits, LDH at diagnosis at the follow up visits, Coombs' assay at diagnosis, alanine-leucine-amino-transferase (ALT) at diagnosis at the follow up visits, total bilirubin at diagnosis at the follow up visits, Troponin above ULN at any point, ADAMTS13 activity (where measured) at diagnosis at the follow up visits, Anti-ADAMTS13 antibodies (where measured) at diagnosis at the follow up visits. The primary objective in this study is the description and quantification of clinical response in terms of platelet count recovery in patients with aTTP treated t with caplacizumab , in addition to PEX and immunosuppression in the real-world setting. The secondary objectives include: number of exacerbations, defined as recurrent thrombocytopenia within 30 days after the end of therapy; rate of relapse, defined as a TTP event occurring more than 30 days after the end of daily plasma exchange; refractoriness; defined by the lack of a doubling of platelet count after 4 days of treatment and a lactate dehydrogenase level that remained above the upper limit of the normal range, TTP-related mortality and evaluation of adverse events.

NCT ID: NCT05135442 Not yet recruiting - Clinical trials for Thrombotic Thrombocytopenic Purpura, Acquired

Efficacy and Safety of Bortezomib as First-line Treatment of Acquired TTP

Start date: December 1, 2021
Phase: Phase 4
Study type: Interventional

To evaluate the efficacy and safety of bortezomib in the first-line treatment of patients with acquired TTP,we design this prospective, multi-center, single-arm interventional study.All enrolled TTP patients were given bortezomib 1.3 mg/m2 intravenous injection d1, 4, 8, on the basis of standard single membrane plasma exchange (2L/d) and hormone therapy (1mg/kg prednisone or equivalent methylprednisolone). 11 (4 doses in total). Bortezomib should be administered immediately after each plasma exchange, and the interval between the next plasma exchange is> 24h. Plasma exchange continued until the patient's platelet count was >100×109/L for 2 consecutive days, and then changed to once every other day for a total of two times and then stopped.

NCT ID: NCT05093257 Not yet recruiting - Clinical trials for Immune Thrombocytopenic Purpura

Study of T Cells and Natural Killer Cells Expression in Patients With Immune Thrombocytopenic Purpura

Start date: November 2021
Phase:
Study type: Observational

Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/L. ITP is classified based on course of disease into acute (3- <12 months), and chronic (≥12 months). ITP usually has a chronic course in adults whereas approximately 80-90% of children undergo spontaneous remission within weeks to months of disease onset. The main pathogenesis of ITP is the loss of immune tolerance to platelet auto-antigens, which results in increased platelet destruction and impaired thrombopoiesis by autoantibodies and cytotoxic T lymphocytes (CTLs). Platelet autoantibodies, particularly antiglycoprotein (GP) GPIIbIIIa and anti-GPIbIX, are known to cause thrombocytopenia in patients with ITP. As a main component of cellular immunity, T cells play an important role in body defense and peripheral tolerance. Changing number and function of these cells is closely associated with various diseases, including ITP.NK cells can also modulate cellular immunity in ITP patients.

NCT ID: NCT04720261 Not yet recruiting - Clinical trials for Thrombotic Thrombocytopenic Purpura, Acquired

Efficacy of a Personalized Caplacizumab Regimen Based on ADAMTS13 Activity Monitoring in Adult aTTP

CAPLAVIE
Start date: May 1, 2021
Phase: Phase 2
Study type: Interventional

The aim of the study is to evaluate the efficacy of a personalized caplacizumab regimen based on ADAMTS13 activity monitoring in adult acquired thrombotic thrombocytopenic purpura (aTTP): This study is a phase II, prospective, multicenter non-inferiority single-arm study.

NCT ID: NCT04311593 Not yet recruiting - Clinical trials for Immune Thrombocytopenia

Prognostic Value of CD Markers in Immune Thrombocytopenic Purpura

Start date: May 2020
Phase:
Study type: Observational

In this study, we will focus on the independent prognostic relevance of the expressions of CD38, CD4, CD56, CD11b and CD19 markers in immune cells with platelet changes in patients with newly diagnosed and chronic ITP.

NCT ID: NCT04128358 Not yet recruiting - Clinical trials for Idiopathic Thrombocytopenic Purpura

Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?

Start date: November 2019
Phase: N/A
Study type: Interventional

Idiopathic thrombocytopenic purpura (ITP) is a benign hematological disorder characterized by isolated thrombocytopenia. Development of antiplatelet autoantibodies is the main pathogenetic mechanism in patients with ITP. However the exact pathogenesis of ITP is complex in which megakaryocyte immune injury and T-cell mediated platelet destruction play significant role. Accordingly treatment of ITP relies mainly on immunosuppression. Recently triple regimen of high dose dexamethasone together with cyclosporine and rituximab was found to induce prolonged remission in patients with ITP compared with single agent immunosuppression. On the other hand this regimen suppresses all immune cells thus predisposing patient to serious infections, which is the main cause of morbidity in ITP furthermore infection enhances autoimmunity. This study will focus on viral hepatitis C and B infection in Egyptian patients with idiopathic thrombocytopenic purpura on Triple therapy and aims to: - Assess and improve preventive measures of blood born hepatitis infection in the hematology ward in Egypt. - Investigate influence of immunosuppression on infection with blood born hepatitis on Egyptian patients with ITP on Triple therapy. - Study the impact of blood born hepatitis infection on clinical outcome on those patients. - Identify risk factors and routes of transmission of blood born viral hepatitis in the hematology ward in Egypt

NCT ID: NCT04113915 Not yet recruiting - Viral Hepatitis Clinical Trials

Viral Hepatitis B and C Infection in Patients With Idiopathic Thrombocytopenic Purpura Treated With Triple Therapy

Start date: November 2019
Phase:
Study type: Observational

Aim of the work To estimate frequency of viral HB & C infection in ITP patients who received triple therapy in comparison with another group treated with steroids only. To explore risk factors and routes of transmission of viral HB & C infection in ITP patients who received triple therapy and the another group treated with steroids . - To assess preventive measures of viral HB& C infection in the hematology ward To investigate the influence of viral HB & C infection on clinical picture, response to treatment and side effects in ITP patients who received triple therapy or steroids.

NCT ID: NCT04021173 Not yet recruiting - Clinical trials for Acquired Thrombotic Thrombocytopenic Purpura

A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)

Start date: July 2019
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study. It is planned to recruit 74 patients with acquired thrombotic thrombocytopenic purpura (TTP). To evaluate the efficacy and safety of Anfibatide as an adjuvant therapy for plasma exchange in patients with acquired TTP.

NCT ID: NCT03692754 Not yet recruiting - Clinical trials for Immune Thrombocytopenia

Atorvastatin in Management of Newly Diagnosed ITP

Start date: November 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of atorvastatin for the treatment of adults with immune thrombocytopenia (ITP).

NCT ID: NCT03443570 Not yet recruiting - Clinical trials for Immune Thrombocytopenia

Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

Start date: March 1, 2018
Phase: Phase 3
Study type: Interventional

The project was undertaking by Qilu Hospital of Shandong University and other 2 well-known hospitals in China. In order to report the efficacy and safety of rituximab combining with bortezomib for the treatment of adults with immune thrombocytopenia (ITP), compared to rituximab alone .