48 results
See section 2.2. of the protocol.The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in NVAF patients undergoing AF…
Am2: Primary Objective* To compare the Overall Survival (OS) benefit of docetaxel and prednisone with and without lenalidomide as first-line combination therapy in chemo-naïve metastatic CRPC Secondary Objectives* Progression-Free Survival (PFS), *…
To study the efficacy of low dose Lenalidomide maintenance combined with bortezomib treatment following non myeloablative Allo-SCT on Event Free Survival.
To asses the comparability of the estimated dabigatran concentration in plasma via calibrated Hemoclot and the measured dabigatran concentrations assessed in a central lab in patients with moderate renal impairment undergoing primary unilateral…
To investigate whether oral administration of dabigatran etexilate in patients with a rhegmatogenous retinal detachment leads to clinical significant dabigatran levels and thrombin inhibiting activity in the vitreous and subretinal fluid.
To determine whether a single dose of 50 IE/Kg PCC is effective in reversing the anticoagulant effect of Dabigatran Etexilate 300mg b.i.d. taken for 2.5 days, as assessed by two modified skin bleeding assays: the "shed blood" and "…
Primary objective:Assesment of feasibility and toxicity of T cell depleted NMA Allo-SCT followed by lenalidomide or lenalidomide combined with bortezomib,and subsequent DLI; as treatment of relapsed multiple myeloma.Secondary objectives:To…
2.1 Primary objective * To determine the feasibility (as measured by non-relapse mortality after 7 months) of the regimen of Ibritumomab, followed by a reduced intensity, partial T cell-depleted allogeneic stem cell transplantation and…
To provide single dose PK/PD dataTo investigate tolerability and safety of dabigatran etexilate solution in children1 to <12 years of age
To investigate the feasibility and efficacy of a maximum of 6 cycles of Chlorambucil with Rituximab plus Lenalidomide at the RDL.
The primary objective is to determine the safety and the maximum tolerated dose of dasatinib in combination with lenalidomide and low dose dexamethasone in subjects with relapsed or refractory multiple myeloma
Phase I:-To determine the maximum tolerated dose (MTD) and recommended phase II dose level (RDL) of Bortezomib administered once weekly, and of Lenalidomide administered for 3 weeks when combined with Dexamethasone in a 28-days schedule.Phase II:-To…
The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…
The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…
To compare progression-free survival in subjects with relapsed multiple myeloma who are receiving CRd vs PFS in subjects receiving Rd alone.
To determine if maintenance treatment with lenalidomide prolongs progression free survival in patients with advanced stage CTCL that has notbeen previously treated with intravenous chemotherapy except the chemotherapy received in the preceeding…
The aim of this phase I study is to assess the extent of intestinal absorption of rivaroxaban and dabigatran etexilate in adult patients with short bowel syndrome and treated with long-term TPN.
To investigate the effect of dabigatran etexilate on airway inflammation, hemostasis and asthma control in patients with severe asthma.
Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of Lenalidomide added to standard induction chemotherapy for AML and select the feasible dose level for part B of the study2. To assess in a randomized…
To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP)…