Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28...
Idiopathic Thrombocytopenic PurpuraThe purpose of this study is to determine the safety and efficacy of AKR-501 (avatrombopag) administered in participants with chronic Idiopathic Thrombocytopenic Purpura (ITP) who were enrolled into and completed 28 days of study treatment in Protocol 501-CL-003 (NCT00441090).
Study In Healthy Subjects To Evaluate The Photo-Irritant Potential Of Eltrombopag
PurpuraThrombocytopaenic1 moreThis study is designed to investigate the safety profile and the photoirritant potential of eltrombopag in healthy subjects. The study is placebo- and positive controlled, randomized, parallel group with three treatment arms: eltrombopag (75 mg QD), placebo, and a positive control (ciprofloxacin, 500 mg BID). Eltrombopag will be administered in a double-blind fashion with respect to placebo and the positive control, ciprofloxacin, will be administered under observer-blinded conditions. Twelve to fifteen subjects will be recruited into each arm, to assure total enrollment of 36 evaluable subjects. The primary endpoint is the photosensitizing potential of eltrombopag as measured by photoirritant index (PI) and change in minimum erythemal dose (MED) in comparison with placebo.
Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients
Idiopathic Thrombocytopenic Purpura (ITP)Idiopathic Thrombocytopenic Purpura (ITP) is an autoimmune bleeding disorder characterised by isolated low platelet counts. The aim of treating patients with ITP is to increase the platelet concentration and reduce the risk of bleeding. A number of controlled multi-centre studies have demonstrated that Intravenous Immunoglobulin (IVIg) therapy produces a rapid rise in platelet counts within a 24 to 72 hour period. This study will evaluate the efficacy and safety of Ig NextGen 10% in adult patients with ITP.
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.
Platelet Response to Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura...
Acquired Thrombotic Thrombocytopenic PurpuraThe interpretation of platelet counts has to be revaluated in the light of caplacizumab. By effectively blocking platelet binding sites on VWF-multimers, the nanobody leads to a rapid normalization of the platelet count within 3 to 4 days. Most importantly, caplacizumab uncouples platelet counts from ADAMTS13 activity and thereby launches unprecedented thrombocyte dynamics, with potential pitfalls for over- and undertreatment. A relevant number of patients responds to caplacizumab with a brisk increase in platelet count, followed by a marked dip of platelets (patient on the left). This may mislead treating physicians into re-intensifying therapy, with a respective risk for adverse side-effects and complications. Taken together, these observations call for reliable descriptions and the identification of predictive parameters to predict the platelet response upon administration of caplacizumab in a large patient cohort. Here, PREDICT-2020 is designed as a retrospective study to specifically address the following aspects: Identifying and describing clusters of platelet responses to caplacizumab Identifying potential pitfalls for treating physicians Predicting the individual thrombocyte response Correlating platelet responses with individual patient outcome
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.
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).
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