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Purpura, Thrombocytopenic clinical trials

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NCT ID: NCT03922308 Completed - Clinical trials for Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

Study of rADAMTS-13 (SHP655) in the Treatment of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

SOAR-HI
Start date: October 9, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment of acquired thrombotic thrombocytopenic purpura (aTTP) participants.

NCT ID: NCT03864796 Completed - Clinical trials for Idiopathic Thrombocytopenic Purpura

Role of CD11a in Pathogenesis of Primary ITP and Effect of Immunosuppressive Therapy on Its Level

Start date: March 1, 2019
Phase:
Study type: Observational

1. The purpose of this study is to investigate the expression of CD11a on subpopulation of lymphocytes and compared its expression between ITP patients and healthy controls and explores its possible role in the pathogenesis of ITP. 2. this may help in decision to use inhibitors (have been developed to block ICAM-1/LFA-1 interactions,) as a line of treatment for ITP and some of these molecules have reached clinical trials. 3. to study if there is correlation between level of CD11a and severity of bleeding at presentation (estimated by bleeding score defined by British Journal of Haematology 2007 and platelet count) 4. to study effect of immunosuppressive treatment on the level of CD11a by evaluating levels of CD11a after response to treatment.

NCT ID: NCT03830749 Completed - Clinical trials for Immune Thrombocytopenia

Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic Purpura

Start date: July 1, 2018
Phase: Phase 2
Study type: Interventional

Current first line treatments for immune thrombocytopenia (ITP) usually have transient effects and prolonged platelet response rate off therapy remains low. The aim is to evaluate whether a 12-week course of eltrombopag plus pulsed dexamethasone as first line therapy can increase the proportion of patients with prolonged response. Diagnosis of ITP is established according to the American Society of Hematology guidelines. Eligible ITP subjects have platelet counts <30×109/L or counts <50×109/L and significant bleeding symptoms (WHO bleeding scale 2 or above). Subjects must have no prior ITP treatment except platelet transfusions. Treatment consists of eltrombopag 25-75 mg daily according to platelet response for 12 weeks plus pulsed dexamethasone, 40 mg daily for 4 consecutive days every 4 weeks for 1-3 courses. The primary endpoint is prolonged response rate which was defined as the proportion of enrolled subjects maintaining platelet counts >50×109/L for more than 6 months without any ITP therapy after completion of 12-week therapy.

NCT ID: NCT03664518 Completed - Clinical trials for Chronic HBV Infection

to Evaluate the Efficacy and Safety of Eltrombopag for Immune Thrombocytopenia With Chronic HBV Infection

Start date: December 4, 2018
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the efficacy of 6-week Eltrombopag to treat immune thrombocytopenia with chronic hepatitis B virus infection. Secondary Objective: To evaluate the efficacy and safety of 6-week and 22-week Eltrombopag to treat immune thrombocytopenia with chronic hepatitis B virus infection.

NCT ID: NCT03524612 Completed - Clinical trials for Immune Thrombocytopenic Purpura (ITP)

A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP

TAPER
Start date: November 2, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this trial was to assess the ability of eltrombopag to induce sustained treatment-free remission in immune thrombocytopenia purpura (ITP) subjects who relapsed or failed to respond to an initial treatment with steroids.

NCT ID: NCT03519672 Completed - Clinical trials for Congenital Thrombotic Thrombocytopenic Purpura

Prospective Psychometric Evaluation Study of a Patient-reported Outcomes (PRO) Instrument for Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP]

Start date: July 12, 2018
Phase:
Study type: Observational

The purpose of this study is to assess the psychometric properties of a recently developed congenital thrombotic thrombocytopenic purpura (cTTP)-specific patient-reported outcomes (PRO) instrument.

NCT ID: NCT03421392 Completed - Clinical trials for Idiopathic Thrombocytopenic Purpura

Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of ICT

SYMPATHIC
Start date: January 1, 2018
Phase:
Study type: Observational

Idiopathic thrombocytopenic purpura (ITP) is the most frequent auto-immune cytopenia. There is no specific biological marker and the diagnosis often results from the exclusion of other differential diagnoses, notably inherited thrombocytopenia. Recent studies have reported an original platelet destruction mechanism in ITP, by antibody-mediated desialylation of membrane proteins. The detection of platelet sialylation can be readily achieved using flow cytometry. This could provide a new biomarker of ITP, useful to ascertain a diagnosis of ITP and guide towards proper patient management.

NCT ID: NCT03412188 Completed - Clinical trials for Idiopathic Thrombocytopenic Purpura

The Effect of Eltrombopag on the Expression of Platelet Collagen Receptor GPVI in Pediatric ITP.

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Using eltronmobag as an alternative pathway, which depend on stimulation of thrombocyte synthesis, in chronic and persistent immune thrombocytopenia may be more promising treatment than the classic type, not only by increasing platelets count but also through enhancing of the platelets activation and upregulation of GPVI expression on platelet surface. This study will include 40 pediatric patients with chronic or persistent ITP, recruited from the Hematology clinic of pediatric hospital Ain Shams University, aiming to investigate the efficacy, & the safety and tolerability of eltrombopag therapy for children as well as the ability of eltrombopag to enhance the platelet activation through the up-regulation of glycoprotein VI (GPVI) receptor expression in comparison with other lines of treatment. Patients will be divided into 2 groups : Group 1 on eltrombopag ; Group 2 : receiving other lines of therapy . All Patients will be subjected to : 1. bleeding score assessment ( baseline &every month ) and Health related quality of life based on Kids' ITP Tools (KIT) questionnaires( baseline and week 24 ) 2. Baseline and at week 24 bone marrow examination with reticulin stain 3. clinical examination every 2 weeks and complete blood counts. 4. Assessment of soluble form of glycoprotein VI using sandwich enzyme-linked immunosorbent assay (ELISA) as well as assessment of platelet activation by GPVI using flowcytometry (Gardiner, etal.,2010 ) at baseline and at the end of 6 months treatment period

NCT ID: NCT03393975 Completed - Clinical trials for Thrombotic Thrombocytopenic Purpura (TTP)

A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP)

Start date: October 13, 2017
Phase: Phase 3
Study type: Interventional

Thrombotic thrombocytopenic purpura (or TTP for short) is a condition where blood clots form in small blood vessels throughout the body. The clots can limit or block the flow of oxygen-rich blood to the body's organs, such as the brain, kidneys, and heart. As a result, serious health problems can develop. The increased clotting that occurs in TTP uses up the cells that help the blood to clot, called platelets. With fewer platelets available in the blood, bleeding problems can occur. People who have TTP may bleed underneath the skin forming purple bruises or purpura, or from the surface of the skin. TTP also can cause anemia, a condition in which red blood cells break apart faster than the body can replace them leading to lower than normal number of red blood cells. A lack of activity in the ADAMTS13 enzyme, a protein in the blood involved in blood clotting, causes TTP. The enzyme breaks up another blood protein called von Willebrand factor that clumps together with platelets to form blood clots. Some people are born with this condition, others get the condition during their life. Many people who born with TTP experience frequent flareups that need to be treated right away. If not treated It can be fatal or cause lasting damage, such as brain damage or a stroke. BAX 930 is a medicine that replaces ADAMTS13 and can prevent or control TTP flareups, called TTP events. The main aim of this study is to compare the number of TTP events in people born with severe TTP when they treated with BAX 930 versus when they are treated with the standard treatment. Treatment will be given in 2 ways: - BAX 930 or standard treatment given to prevent TTP events from happening. - BAX 930 or standard treatment given to control an acute TTP event when it happens, according to the clinic's standard practice. Both BAX 930 and standard treatment are given slowly through a vein (infusion). At the first visit, the study doctor will check if you can participate in the study. If you are eligible and enter the study, you will follow an assigned schedule and either start with BAX 930 (Period 1) and then switch to standard treatment (Period 2) or start with standard treatment (Period 1) and then switch to BAX 930 (Period 2). Everyone will be treated with BAX 930 again for Period 3. Each Period will last approximately 6 months. If you enter the study to control an acute TTP event, you will follow a schedule receiving either BAX 930 or standard care to treat your acute TTP event. Once the acute TTP event has gotten better, you can decide to continue in the study and be given treatment to prevent TTP events from happening, following the schedule above. Another study's aim is to assess side effects from treatment with BAX 930 and standard treatment. To do that, the study doctor will ask you questions about your health at each study visit. The study doctors will also check how long BAX 930 stays in the blood of the participants, over time. They will do this from blood samples taken after participants receive their specific infusions of BAX 930. This will happen at different times during the study. 1 month after all treatment has been completed, participants will visit the clinic for a final check-up.

NCT ID: NCT03369314 Completed - Clinical trials for Thrombotic Thrombocytopenic Purpura

Observational Study of the Use of octaplasLG®.

Start date: March 2, 2018
Phase:
Study type: Observational

This observational study enrolls patients who have received at least one infusion of octaplasLG®. OctaplasLG® will be administered standard of care and observation occurs during the treatment and 24 hours after the end of treatment. Characteristics of the use of octaplasLG®, tolerance criteria, and efficacy criteria will be collected.