A Randomized Study of IVIG vs. IVIG With High Dose Methylprednisolone in Childhood ITP.
Immune Thrombocytopenic PurpuraChildhood immune thrombocytopenia purpura (ITP) is a disorder characterized by the production of antibodies against platelets, resulting in enhanced destruction of platelets. Most children with ITP present with low platelet counts (PC) but minimal bleeding. Very rarely a child may present with a severe life-threatening bleed, such as a bleed in the head. In this case it is very important that the PC be raised as quickly as possible. The combination of corticosteroids and intravenous gammaglobulin (IVIG) is commonly used in the management of such severe bleeding in children with ITP to quickly raise the PC and yet this treatment combination has not been tested against using IVIG alone. If it is shown that the combination of these agents does result in a quicker rise in PC then when using IVIG alone would support the use of this combination therapy in emergency situations. As we can not ethically conduct this study in patients with life-threatening bleeds, we plan to study patients with ITP and PC less than 20 X 109/L, but without life threatening bleeding. Eligible patients will be randomized to one of these 2 regimens (IVIG + placebo or IVIG + IV corticosteroids). The study is designed as a double-blind trial, where the patient or the treating physician will not be aware of the regimen that a patient is randomized to. PC's will be measured as a surrogate measure of bleeding risk; bleeding scores (a score generated by observing patients for bleeding symptoms) will be used to grade bleeding severity, and adverse effects to treatment will be monitored by the means of questionnaires throughout the study.
Efficacy and Safety of IVIG-L in ITP Patients
PurpuraThrombocytopenic1 moreThe efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, in patients with ITP will be assessed and compared with data obtained from literature.
Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in...
Immune Thrombocytopenic Purpura (ITP)The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.
A Study of Zanubrutinib in Patients With ITP
Immune ThrombocytopeniaBruton Tyrosine KinaseThis project was undertaken to evaluate the efficacy and safety of BTK inhibitor Zanubrutinib for the secondary treatment of adults with primary immune thrombocytopenia (ITP).
A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic...
Immune Thrombocytopenic PurpuraThe purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia...
Immune ThrombocytopeniaThis is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10^9/L in the absence of ITP rescue medications for the past 4 weeks.
The Combination of ATRA and Danazol as Second-line Treatment in Adult Immune Thrombocytopenia
Autoimmune ThrombocytopeniaRandomized, open-label, multicentre study to compare the efficacy and safety of ATRA plus danazol with danazol monotherapy in patients with corticosteroid-resistant/relapsed ITP.
Eltrombopag and High-dose Dexamethasone as First Line Treatment for IT
Immune Thrombocytopenic PurpuraThe purpose of this study is to determine the response rate and response duration with the combination of eltrombopag and high-dose dexamethasone
Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia
Immune Thrombocytopenic PurpuraA comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this study is to compare the efficacy and tolerability of two different regimens of low doses rituximab for the treatment of adult patients with ITP.
This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia...
Immune ThrombocytopeniaThe main purpose of this study is to assess the efficacy and safety of BT595 in adult subjects with chronic ITP. The primary objective of this study is to determine the rate of subjects with a response. A response is defined as a platelet count of ≥30×10^9/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding. The secondary objectives of this study, in addition to further efficacy assessments, are to evaluate the safety of BT595.