90 results
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…
The purpose of the study is to investigate the ability of MYL-1401H to evoke an immune response (immunogenicity) as compared to Neulasta® US. In addition, the effect of MYL-1401H on blood cells as compared to Neulasta® US will be investigated. The…
Study Objectives:Primary Objective* To determine the safety profile of long-term MLN0002 treatmentResource Utilization and Patient-Reported Outcome Objectives* To determine the effect of long-term MLN0002 treatment on time to major inflammatory…
assess the contraceptive efficacy and safety of the etonogestrel (ENG) 125 + 17*-estradiol (E2) 300 µg /day vaginal ring
Primary:The primary objective is to determine the safety and tolerability of the combination treatment, i.e. GCb, VPA and GCV, by evaluation of adverse events (AE*s) serious adverse events (SAE*s) and all clinically significant changes in clinical…
Primary objective:the primary objective of the study is to evaluate the safety and to define the maximal tolerated dose or the maximal administered dose of CC-486 as a single agent, in combination with CBDCA or ABI-007 in subjects with relapsed or…
Primary: The primary objective of the study is to evaluate the long-term safety of rFIXFc in subjects with hemophilia B.Secondary: The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of…
To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low-dose cytarabine in patients * 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction…
The primary objective is to compare the efficacy of two dose-schedule arms(s) of pacritinib (pooled once daily [QD] and twice-daily [BID] dosing arms) with that of best available therapy (BAT) in patients with thrombocytopenia and primary…
Primary:- To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing forms of multiple sclerosis as compared with baseline values and those of a reference population of untreated healthy subjects.Secondary:- To assess…
Primary ObjectivesPhase 1 portion:• to determine the maximum tolerable dose (MTD) of cytarabine (up to 2 g/m2/day x 5) that can be administered on Days 8-12 following treatment with DACOGEN 20 mg/m2/day on Days 1-5 of a 28 day cycle. • to determine…
Primary Objectives-To compare the efficacy responses of CP-690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP-690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16-week double-blind…
The purpose of this extension is to provide continued treatment and to assess the long term safety, efficacy and tolerability of oral AEB071 plus Certican® vs. Neoral® plus Certican® in de novo renal transplant recipients. The study is a…
To assess the bioequivalence of 6 mg dexamethasone tablet administered PO as an alternative to 5,26 mg dexamethasone-disodiumphosphate (= 4 mg dexamethasone) solution administered IV
The first aim of the study is to investigate the effect of telaprevir on the concentration of LPV/rtv and ATV/rtv in the blood and the effect of LPV/rtv and of ATV/rtv the concentration of telaprevir in the blood.The second aim is to investigate the…
The goal of this trial is to confirm that eradication rates obtained with Pylera are compatible to those obtained with the current European gols standard, OAC 7 days. This trial will constitute a pivotal trial leading eventually to approval of…
The primary objective is to determine the effect of co-administration of telepravir, given as 2 tablets of 375 mg every 8 hours and DRV/rtv or fAPV/rtv on the amount of telaprevir and DRV/rtv or fAPV/rtv in the body. The secondary objective is to…
The primary objective of this study is to determine whether the pharmacokinetics of midazolam show circadian rhythmicity.
We here propose a pilot immuno-PET study in active relapsing MS patients to investigate safety and sensitivity of 89Zr-rituximab in detecting CD20 positive (active) MS lesions and to assess inter-patient variability in 89Zr-rituximab biodistribition…
CAEB071A2206 will assess safety, efficacy and target trough levels for optimal dosing of AEB071 combined with Certican in a CNI-free regimen in de novo renal transplant recipients. This study will combine the investigational drug AEB071 with an…