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Purpura clinical trials

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NCT ID: NCT02317133 Completed - Clinical trials for Henoch Schönlein Purpura

Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura

FOX-TREG
Start date: February 2015
Phase:
Study type: Observational

The primary objective of this study is to search for evidence of quantitative or functional defects in plasma regulatory T cells (Tregs) in pediatric patients with Henoch Schönlein Purpura (HSP) as compared to a control population.

NCT ID: NCT02281370 Completed - Clinical trials for Purpura, Thrombocytopenic, Idiopathic

Drug-drug Interaction Study of Eltrombopag and Cyclosporine in Healthy Subjects

Start date: November 5, 2014
Phase: Phase 1
Study type: Interventional

A drug-drug interaction study between eltrombopag and cyclosporine is being conducted to support the use of these drugs together in subjects, such as those with severe aplastic anemia or immune thrombocytopenia purpura. The primary objective of the study is to evaluate the effect of cyclosporine on the pharmacokinetics of eltrombopag. This is a Phase I, open-label, randomized, three-period cross-over study in healthy adult subjects. The study consists of a screening visit and three treatment periods. All subjects will be randomized to receive one of the three treatments in each treatment period separated by washout periods of 3-10 days. The total duration of a subject's participation in the study from screening to final discharge is up to approximately 6 weeks (assuming 3 day washouts between treatment periods). Approximately 39 healthy subjects will be enrolled with the goal of completing at least 10 subjects per sequence (total 30).

NCT ID: NCT02273960 Completed - Clinical trials for Immune Thrombocytopenic Purpura

Study to Evaluate Safety and Efficacy in Adult Subjects With ITP

ITP
Start date: November 17, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP.

NCT ID: NCT02238795 Completed - Sepsis Clinical Trials

Sepsis-Associated Purpura Fulminans International Registry - Europe

SAPFIRE
Start date: April 2016
Phase:
Study type: Observational [Patient Registry]

Sepsis-associated Purpura fulminans (SAPF) is a rare life-threatening condition. It is characterized by multiple skin lesions which rapidly progress to necrosis and gangrene. SAPF is a manifestation of widespread clot formation in small blood vessels which emerges secondarily to severe bacterial and viral infections. The clinical presentation of SAPF is dominated by symptoms of severe sepsis and multiple organ failure which are further aggravated by the massive skin lesions. At present, there are no evidence-based guidelines for the medical management of SAPF. With numerous therapeutic approaches in use, there are no consistent comparisons of their efficacy. Altered role of causal pathogens following the introduction of meningococcal and pneumococcal prophylactic vaccines also remains to be investigated. The goal of the registry is comprehensive collection and evaluation of information concerning the epidemiology, morbidity, therapy and outcome of SAPF.

NCT ID: NCT02216084 Completed - Clinical trials for Hereditary Thrombotic Thrombocytopenic Purpura (TTP)

Phase 1 Dose Escalation, Single Dose Study to Assess Safety and Pharmacokinetics of BAX930 in Hereditary Thrombotic Thrombocytopenic Purpura (TTP)

Start date: September 30, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this Phase 1, prospective, uncontrolled, open-label, multicenter, dose-escalation study is to evaluate the safety, including immunogenicity, and pharmacokinetics of BAX930 (rADAMTS13) in a total of 14 evaluable subjects diagnosed with severe hereditary thrombotic thrombocytopenic purpura (TTP) (plasma ADAMTS13 activity <6%) who are assigned to one of three dose cohorts.

NCT ID: NCT02201290 Completed - Clinical trials for Purpura, Thrombocytopenic, Idiopathic

A Long-term Safety Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Start date: June 18, 2013
Phase: Phase 3
Study type: Interventional

This was an open-label Phase III extension study to evaluate the long-term safety of eltrombopag in pediatric patients with chronic ITP who previously participated in study TRA115450. This study allowed dosing of eltrombopag at an individualized dose for each subject based upon platelet count. The starting dose was based on the subject's dose at the end of the TRA115450 study. The maximum dose was 75 mg daily.

NCT ID: NCT02134171 Completed - Clinical trials for Thrombotic Thrombocytopenic Purpura

Early Predictive Factors of Cardiac and Cerebral Involvement in TMA

MATRISK
Start date: June 10, 2014
Phase: N/A
Study type: Interventional

The aim of this study is to determine the frequency of cardiac and cerebral involvements in patients with idiopathic thrombotic microangiopathies on diagnosis. Patients will be assessed for cardiac involvement (troponin Ic level and cardiac ultrasonography) and cerebral involvement (cerebral MRI). The investigators will assess whether serum troponin Ic on diagnosis can predict morbidity and mortality of patients with a thrombotic microangiopathy at the acute phase. The primary outcome measurement is the event free survival at day 30, as defined by death, myocardial ischemia, arrhythmia, severe cerebral injury and disease exacerbation. An increase in troponin Ic on diagnosis is defined as at least one result above 0.2 ng/ml among the three daily analyses performed after TMA diagnosis.

NCT ID: NCT02085993 Completed - Clinical trials for Immune Thrombocytopenic Purpura

Study of Patients With ITP Estimating the Proportion Administering Romiplostim Correctly After Receiving Home Administration Training

Start date: July 2014
Phase: N/A
Study type: Observational

Cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. Further observations can also be recorded in the study if made within 16 weeks of enrolment. Data will be collected from the subjects' dose diary at their first standard of care visit to ensure there were no problems with administration while not at the clinic.

NCT ID: NCT02077192 Completed - Clinical trials for Immune Thrombocytopenic Purpura

Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

Start date: October 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP

NCT ID: NCT02076412 Completed - Clinical trials for Immune Thrombocytopenic Purpura

A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

FIT
Start date: January 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).