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7-day study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties
of oral rivaroxaban in children from birth to less than 6 months with arterial or venous
thrombosis

The primary objective is:- to characterize the pharmacokinetic/pharmacodynamic profile of a 7-day treatment with oral rivaroxabanThe secondary objectives are:- to assess the incidence of major bleeding and clinically relevant non-major bleeding- to…

30-day, single-arm study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in children with various manifestations of venous thrombosis.

-Assess the incidence of major bleeding and clinically relevant non-major bleeding -Assess the incidence of recurrent venous thromboembolism -Characterize the pharmacokinetic/ pharmacodynamic profile of a 30-day treatment with oral rivaroxaban

Umbilical cord blood transplantation in high-risk hematological patients using stemregenin-1 expanded hematopoietic stem cells.
A feasibility study focussing on engraftment and hematopoietic recovery.

To study the feasibility of single UCBT with one ex-vivo SR-1 expanded unitTo assess side effects and TRM after single UCBT with one expanded unitTo assess engraftment and engraftment kinetics; to evaluate immune reconstitution, acute and chronic…

Double umbilical cord blood transplantation in high-risk haematological patients.
A phase II study focussing on the mechanism of graft predominance

Objective of the study is to evaluate whether parameters can be identified that predict which graft ultimately prevails following cord blood transplantation after a reduced intensity conditioning regimen in adult patients .In addition engraftment,…

An open-label, uncontrolled, multicenter, multinational study on the efficacy and safety of administration of donor lymphocytes depleted of alloreactive T-cells (ATIR), through the use of TH9402 and light treatment in an ex vivo process, in patients receiving a CD34-selected peripheral blood stem cell graft from a related, haploidentical donor.

Primary objective:• To study the effects of the administration of a donor lymphocyte preparation selectively depleted of host alloreactive T cells (ATIR) to patients with hematologic malignancies on 6 months and 12 months transplant related…

Co-infusion of haematopoietic stem cells from a haplo-identical donor and single unit unrelated cord blood in patients with a high risk of relapse:
A Phase l/ll study to assess safety and to investigate the biological mechanism of the anti-tumor response

To study the safety of co-infusion of a alphabetaT-/CD19 B-cell depleted haematopoietic stem cells from haplo-identical donor and a single unit cord blood unit and to investigate the anti-tumor responses from both grafts.

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Subjects with International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome

The primary objective is to assess the clinical efficacy of siltuximab (a chimeric (murine-human) IgG1* mAb that specifically binds human IL-6 with high affinity and prevents its interaction with the IL-6 receptor, glycoprotein (GP) 80),…

Randomized double blind placebo controlled PK/PD study on the effects of a single intravenous dose of NOX-H94 on serum iron during experimental human endotoxemia

Primary Objective•To assess the pharmacodynamic response after single dose administration of NOX H94 in healthy subjects during experimental endotoxemia.Secondary Objective• To determine the pharmacodynamic effects of NOX H94 after single dose…

A Three-part Study of Eltrombopag in Thrombocytopenic Subjects with Myelodysplastic Syndromes or Acute Myeloid Leukemia (Part 1: open-label, Part 2: randomized, double-blind, Part 3: extension).;ASPIRE: A Study of EltromboPag In Myelodysplastic SyndRomes and AcutE Myeloid Leukemia

Part 1 (open-label, 8 week): safety and tolerability of eltrombopag, optimal dose escalation scheme for use in Part 2, PK.Part 2: Primary: the reduction in the number of clinically relevant thrombocytopenic events (*Grade 3 hemorrhagic adverse…

Bortezomib in combination with continuous low-dose oral cyclophosphamide and dexamethason followed by maintenance in primary refractory or relapsed bortezomib naïve multiple myeloma patients

Evaluation of the safety and efficacy of bortezomib combined with cyclophosphamide and dexamethasone for induction and maintenance therapy.

An Open Label Study of AMG 531 in Severely Refractory Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Primary:To demonstrate the safety of AMG 531 in severely refractory thrombocytopenic subjects with ITPSecondary:To monitor hematological responses to AMG 531To provide open-label use of AMG 531, and to investigate its utility in severely refractory…

Can the steady-state hematopoiesis be improved post-ASCT by infusion of the autologous stem cell transplant directly in the bone marrow compartment?

To improve the steady hematopoiesis post-ASCT by infusing the autologous transplant directly in the bone marrow compartment.(protocol page 6)

AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)

Objectives: The following trial objectives for adolescent patients (from 12 and up to 18 years of age) with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS) are to:Primary:* Assess the effect of eculizumab on TMA-Event Free status…

AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)

Objectives: The following trial objectives for adult patients with plasma therapy-resistantAtypical Hemolytic-Uremic Syndrome (aHUS) are to:Primary:• Assess the effect of eculizumab to reduce thrombotic microangiopathy (TMA) asindicated by…

AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)

Objectives: The following trial objectives for adult patients with plasma therapy-resistantAtypical Hemolytic-Uremic Syndrome (aHUS) are to:Primary:• Assess the effect of eculizumab to reduce thrombotic microangiopathy (TMA) asindicated by…

Randomized, active-controlled, double-blind, parallel design study to evaluate the efficacy and safety of a once-a-week prophylaxis treatment with BAY 79-4980 compared to three times-per-week prophylaxis with rFVIII-FS in previously treated patients with severe hemophilia A

The primary objective is to evaluate the effect of a once-a-weekprophylaxis regimen with BAY 79-4980 on the protection from all bleeds compared to a three times-per-week prophylaxis regimen with rFVIII-FSWFI.

Efficacy and safety of canakinumab in Schnitzler syndrome

Primary: To determine whether IL-1 inhibition by Canakinumab is efficacious in treatment of Schnitzler syndrome.Secondary:1. To assess the effect of canakinumab on Schnitzler syndrome (clinical signs/symptoms and inflammatory biomarkers C-reactive…

An Open-label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients with Atypical Hemolytic-Uremic Syndrome

Assess the efficacy and safety of eculizumab in pediatric patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.

An Open-Label, Multi-Center Clinical Trial of Eculizumab in Adult Patients with Atypical Hemolytic-Uremic Syndrome

Assess the efficacy of eculizumab in adult patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.

An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab
in Adult Patients with Plasma Therapy-Sensitive Atypical Hemolytic-Uremic Syndrome (AHUS)

Objectives: The following trial objectives for adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS) are to:Primary:* Assess the effect of eculizumab on TMA-Event Free status defined as the absence of [1] decrease in…