17 results
The primary goal of the current study is to study the safety of and serological response to the MMR booster vaccination in JIA patients. Based on a retrospective analysis we hypothesize that MMR vaccination does not aggravate JIA disease and that…
To determine the maximum tolerated dose (MTD), dose limiting toxicities (DLT), and optimal dose of docetaxel that can safely be administered to patients with cancer in a weekly schedule. amendment 1The objective of the first amendment is to…
To measure APC resistance and SHBG levels as indicators of the risk of venous thrombosis during use of the new developed combined oral contraceptive containing dienogest/estradiolvalerate (Qlaira®) compared with a combined oral contraceptive…
To compare the effects on the APC- (Activated Protein C) resistance ratio (ETP-[endogenous throbin potential] based) between the pivotal phase III NOMAC-E2 batch and a commercial NOMAC-E2 batchTo compare the effects on all other metabolic parameters…
Objective: To investigate the safety and efficacy of a therapy consisting Everolimus and corticosteroids maintenance immunosuppressive regime twelve months after renal transplantation in recipients of donor kidney graft on graft function and acute…
The purpose of this study is: • To examine how the combined oral contraceptive pill, which consists of 30 micrograms ethinyl-estradiol and 150 micrograms levonorgestrel (for instance Microgynon 30®), will be absorbed, metabolized and excreted by the…
Primary: To demonstrate the efficacy of QGE031 relative to placebo at 12 weeks in patients withatopic dermatitis (AD) as assessed by Eczema Area and Severity Index (EASI).Secondary: efficacy assessed by Investigator Global Assessment (IGA, 12 weeks…
Primary objective:To compare the effects of quick starting a combined oral contraceptive on follicular growth and hormonal parameters after ellaOne® or placebo intake.Secondary objective:To compare the effects of quick starting a combined oral…
The purpose of the study is to investigate how quickly Danoprevir is absorbed and the extent of absorption and elimination from the body (this is called pharmacokinetics and bioavailability) when it is administered intravenously (IV) or orally alone…
Objectives:To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose. The secondary objective is to…
Objectives. The goals of the current protocol is therefore the natural follow-up of the objectives achieved with the previous grants and, in particular, of projects designed to discern new models for the successful conduct of clinical trials in…
This study is designed to demonstrate equal therapeutic effect of Myfortic® as compared to MMF in this patient group, thus improving therapeutic efficacy.
To characterize the exposure-response relationship of MVT-602 effects on luteinizing hormone (LH) concentrations after subcutaneous administration of single 0.1 to 3 µg doses of MVT-602 or placebo in healthy premenopausal women undergoing COS to…
The main objective of this study is to investigate whether kidney transplant recipient suffering from a tacrolimus-induced tremor can benefit from switching from conventional tacrolimus to LCPT, a new extended release preparation of tacrolimus (…
Primary: to evaluate the effect of everolimus with reduced exposure CNI versus MPA with standard exposure CNI on the binary composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50mL/min/1.73m2 at Month 12 post-transplantation.…
Primary: To evaluate the efficacy of eltrombopag + cyclosporine as first-line therapy on overall hematologic response (neutrophil, platelet, hemoglobin) by 6 months.Secondary: Overall hematologic response (neutrophil, platelet, hemoglobin) by 3 and…
To compare the efficacy of alitretinoin and cyclosporine in the treatment of hand eczema.