13 results
Primary ObjectiveThe primary objective is to compare the annualized rates of bleeding episodes (ABR)between subjects receiving a prophylactic regimen of BAX 855 with an on-demandtreatment regimen.Secondary ObjectivesThe key secondary objective is to…
To provide access to Radium-223 dichloride to patients diagnosed with CRPC/HRPC with bonemetastasis.
7.2 Primary ObjectiveThe primary objective is to assess the incidence of FVIII inhibitory antibodies(>=0.6 Bethesda units [BU] using the Nijmegen modification of the Bethesda assay).7.3 Secondary Objectives1. To evaluate the PK parameters of…
To investigate whether peri-operative dosing using a population-based pharmacokinetic model (non-linear mixed effect modelling) in hemophilia patients leads to a significant reduction in clotting factor consumption in comparison to the standard…
Study Rationale and ObjectivesThe objective of the study is to determine the efficacy and safety of lacosamide, a sodium channel blocker, in patients with pain due to SCN9A-associated SFN. The proposed study plans to recruit patients with clinically…
The objective of this study is to assess the efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative), hormone receptor positive breast cancer with bone metastases treated with…
The objective of this study is to assess efficacy and safety of radium 223 dichloride in combination with exemestane and everolimus in subjects with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor positive breast cancer…
1. To assess tolerability and safety of BAX 826 after a single infusion in previously PTPs with severe hemophilia A.2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE.3. To evaluate the impact of anti- PSA antibodies…
The objective of this trial is to compare standard treatment with radium-223-chloride (proven surivval benefit) with treatment with rhenium-188-HEDP, which is nowadays only used for pain palliation. This trial includes patients with metastatic…
To evaluate the efficacy of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in adult and pediatric / adolescent subjects (aged 12 to <18 years) during the…
The objective of the study is to quantify the effect of pregabaline and lacosamide on oxycodone-induced respiratory depression.
DDAVP treatment combined with FVIII clotting factor concentrates in patients with mild hemophilia A.
Primary objectives:To assess the proportion of non-severe hemophilia A patients within FVIII target levels with the DDAVP and FVIII concentrate combination treatment in the first 72 hours after the start of combination treatment, without adding off-…
to provide access to Radium-223 dichloride together with abiraterone and prednisone to patients diagnosed with CRPC with bonemetasasis.