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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…

A Phase II/III, multicenter, partially randomized, open label trial investigating safety and efficacy of on-demand and prophylactic treatment with BAY 94-9027 in Severe Hemophilia A

PART A: To assess the efficacy of BAY 94-9027 in prevention and treatment of bleeding at different infusion schedules.PART B: To assess the safety and efficacy of BAY 94-9027 in the prevention of bleeding during major surgical procedures.

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…

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.

ADDED VALUE OF 18FDG-PET-CT IN THE DIAGNOSIS OF INVASIVE FUNGAL INFECTIONS IN NEUTROPENIC PATIENTS

Objective: The primary objective of this pilot study is to compare FDG-PET-CT with HR-CT alone and to HR-CT and galactomannan test together for early diagnosing IFIs in neutropenic patients.

Randomized, Double-blind, Placebo-controlled, Crossover Design, Efficacy and Safety
Study with PA101 in Patients with Indolent Systemic Mastocytosis

Primary:* To determine the efficacy profile of PA101 delivered via a high efficiency nebulizer (eFlow®,PARI) in comparison with placebo following 6 weeks of treatment in patients with indolentsystemic mastocytosis (ISM) who are symptomatic despite…

Therapy of Refractory Inhibitors with immUne Modulation in Patients with Hemophilia. The TRIUMPH trial

To evaluate the efficacy, safety and feasibility of combined immune modulation with rituximab, ITI and MSCs in terms of eradication of FVIII inhibitory activity in hemophilia A patients.

Coversin in paroxysmal nocturnal haemoglobinuria (PNH) in patients with resistance to eculizumab due to complement C5 polymorphisms (VIP study 578)

To determine the safety and efficacy of coversin in the treatment of patients with PNH resistant to eculizumab.

A multicenter study of apheresis collection of peripheral blood mononuclear cells (PBMC) in patients with CD19 expressing malignancies who could be eligible for a CTL019 clinical research trial

The rationale for this protocol is to use standardized procedures to obtain PBMCs from adult patients with a diagnosis of a CD19 expressingmalignancy for which a CTL019 treatment protocol is currently enrolling or under IRB/EC review, and to…

30-day, single-arm study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in young 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- Assess the asymptomatic deterioration in the thrombotic burden on repeat imaging- Characterize the…

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 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…

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 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…

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.

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,…