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Thrombocytopenia clinical trials

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NCT ID: NCT01965626 Completed - Thrombocytopenia Clinical Trials

A Multicenter Randomized Open-label Study of Oseltamivir Combined With HD-DEX Versus HD-DEX in the Management of ITP

Start date: February 1, 2016
Phase: Phase 2
Study type: Interventional

Oseltamivirphosphate is hydrolysed to its active metabolite-the free carboxylate of oseltamivir. Oseltamivir is a neuraminidase inhibitor, serving as a competitive inhibitor of the activity of the viral neuraminidase (NA) enzyme upon sialic acid, found on glycoproteins on the surface of platelets. By blocking the activity of the enzyme, oseltamivir may prevent platelet destruction in liver.The project was undertaking by Qilu Hospital of Shandong University and other 4 well-known hospitals in China. In order to report the efficacy and safety of oseltamivirphosphate combined with high-dose dexamethasone for the treatment of immune thrombocytopenia (ITP) with high platelet desialylation level, compared to high-dose dexamethasone therapy.

NCT ID: NCT01963260 Completed - Clinical trials for Immune Thrombocytopenia Purpura

Single Rising Dose Study of MK-8723 in Healthy Participants and Participants With Immune Thrombocytopenia Purpura (MK-8723-001)

Start date: October 31, 2013
Phase: Phase 1
Study type: Interventional

The primary objectives of this study are to assess the safety and tolerability of single rising doses of MK-8723 in healthy adult participants and adult participants with chronic immune thrombocytopenia purpura (ITP) and to assess pharmacodynamics of MK-8723 in participants with ITP. The primary hypothesis is that the true placebo-adjusted platelet response rate to MK-8723 in adult patients with chronic ITP is >50%.

NCT ID: NCT01957176 Completed - Thrombocytopaenia Clinical Trials

A Rollover Study to Provide Continued Treatment With Eltrombopag

Start date: October 15, 2013
Phase: Phase 4
Study type: Interventional

The objective of this study was to provide continued treatment with eltrombopag for subjects who were participating in a Novartis-sponsored investigational study with eltrombopag (parent studies 114968/ASPIRE (NCT01440374), PMA112509 (NCT00903422), and TRA105325/EXTEND (NCT00351468), receiving clinical benefit without unacceptable toxicity and to collect long-term safety data.

NCT ID: NCT01955811 Completed - Blood Clotting Clinical Trials

Study to Reveal if Fibrinogen Treatment Effects Blood Clotting Better Than a Platelet Transfusion

FiT2012
Start date: December 2012
Phase: Phase 4
Study type: Interventional

Patients with need of platelet transfusion for any reason will participate in this study. Directly before the start of infusion and one hour after the end of platelet transfusion blood samples will be drawn and treated with different concentrations of Fibrinogen (a blood clotting factor) in-vitro. Blood samples with and without Fibrinogen/platelet transfusion will be compared. The study hypothesis is that treatment with Fibrinogen results in a better stabilisation of blood coagulation.

NCT ID: NCT01933035 Completed - Clinical trials for Immune Thrombocytopenia

Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.

Start date: October 2013
Phase: N/A
Study type: Observational [Patient Registry]

To utilise extended platelet parameters in order to individuate Immune Thrombocytopenia (ITP) from hypo-proliferative causes of thrombocytopenia. To develop the clinical potential of the extended platelet parameters as they pertain to distinguishing different causes of thrombocytopenia from one another. To test the hypothesis that mean platelet component (MPC) and mean platelet mass (MPM) might distinguish between thrombocytopenia related to bone marrow dysfunction and immune mediated destruction of platelets.

NCT ID: NCT01928017 Completed - Lymphoma Clinical Trials

Thromboelastography, Platelet Function and Platelet Recovery in Haemato-oncologic Patients With Thrombocytopenia

Start date: June 2013
Phase: N/A
Study type: Observational

This is a prospective observational clinical study to characterise abnormalities of thromboelastography (TEG) parameters in patients with chemotherapy-induced thrombocytopenia. The investigators are also studying the relationship between Multiplate analysis and bleeding in these patients and the effect of platelet transfusions on thrombopoietin level and percent reticulated platelets. The investigators' hypothesis is that changes in TEG-parameters reflect the patients tendency to bleed.

NCT ID: NCT01880047 Completed - Clinical trials for Immune Thrombocytopenia

Safety and Efficacy of Eltrombopag at Escalated Doses

Start date: February 2013
Phase: Phase 2
Study type: Interventional

Study rationale is based on the data that in previous clinical studies of eltrombopag in ITP there are some patients who have been reported as non responders at the maximal approved dose of 75 mg daily. The trend in both normal volunteers and in patients with ITP suggest and increasing response rate with increased doses of eltrombopag up to a dose of 75mg. Previously published data has shown no overt increase in toxicity in normal volunteers, oncology patients and aplastic anemia patients treated with escalated doses as high or higher than those proposed in this study. It therefore seems possible that in ITP patients who did not respond to a dose of 75mg daily, eltrombopag could be more effective at a higher dose. We propose a double blind randomized controlled trial in ITP patients who have been defined as non-responders at the maximum dose (75mg) of eltrombopag, assessing efficacy and toxicity at higher daily doses (100mg, 125 mg, 150 mg)

NCT ID: NCT01808521 Completed - Clinical trials for Purpura, Thrombotic Thrombocytopenic

A Pilot Study of N-acetylcysteine in Thrombotic Thrombocytopenia Purpura

NACinTTP
Start date: May 2013
Phase: Early Phase 1
Study type: Interventional

In this study, the investigators want to determine if N-acetylcysteine(NAC), given intravenously, will decrease complications in patients with Thrombotic Thrombocytopenia Purpura (TTP) who are receiving treatment with therapeutic plasma exchange (TPE). The investigators want to determine, through anti-oxidant activity, if NAC will have additional efficacy in TTP by improving cleavage of the patients' VWF by ADAMTS13, and preventing propagation of platelet/VWF strings. This will be manifest by a more rapid improvement in the patient's platelet count, decrease in number of days requiring TPE, and decrease in microvascular thrombotic complications. The investigators will additionally: 1) Assess safety of NAC by evaluating subjects for adverse events and significant adverse events 2) Determine effects on TTP by measuring clinical and research laboratory values 3) Determine drug effects by measuring clinical and research laboratory values.

NCT ID: NCT01791101 Completed - Thrombocytopenia Clinical Trials

Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia.

ITP0511
Start date: September 16, 2013
Phase: Phase 2
Study type: Interventional

This is a Phase II multicentre study. Patients will be administered eltrombopag 50 mg/daily. If patients don't achieve response after 2 months of therapy they will stop eltrombopag; if patients will achieve response after 2 months of therapy, they will continue eltrombopag for a maximum period of 24 months; 40 patients are needed. In stage I, 22 patients will be enrolled; if ≤ 4 responses at the first evaluation after 2 months (18%) will be seen, the trial will be stopped; if 5 or more responses will be seen, the accrual will continue. In stage II, 18 more patients will be enrolled. If ≤ 12 (30%) responses will be observed out of 40 patients, it will be concluded that the study drug is not active enough. If ≥ 13 responses will be observed, it will be concluded that eltrombopag is worth of further studies.

NCT ID: NCT01789762 Completed - Clinical trials for Aplasia With Expected Thrombocytopenia

Evaluation of the Efficacy of Platelets Treated With Pathogen Reduction Process

EFFIPAP
Start date: May 2013
Phase: Phase 4
Study type: Interventional

This study is a multicentre, double-blind, randomized therapeutic trial. The primary objective of this study is to evaluate non-inferiority with regard to prevention and control of haemorrhage: - of platelet concentrates treated by pathogen reduction(Intercept amotosalen and UVA procedure) - compared with the usual platelet concentrates (in additive solution intersol), reference arm, and - compared with platelet concentrates re-suspended in autologous plasma (historic arm) These three products are available and authorised by ANSM (formerly AFSSAPS). The secondary objectives is to evaluate the transfusion needs, transfusion outcomes and safety and the decreased frequency of grade 2 or higher side effects related to transfusion allergy to platelets.