16 results
The objective of this study is to assess the distribution of infusion associated reactions (IARs) by severity grade when Lemtrada is administered to RRMS patients who will be medicated according to specified algorithm designed to manage infusion…
The objectives of this study are to compare the safety and efficacy of 2 annual cycles of intravenous (IV) alemtuzumab to 3-times weekly subcutaneous (SC) interferon beta 1a (Rebif*) in patients with active relapsing-remitting multiple sclerosis (…
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…
Primary: Dose finding for a twice daily regimen for PSZ as prophylactic treatment in children with CGD, based on the exposure to PSZ measured by PSZ trough levels.Secondary:To determine the tolerability of PSZ as prophylactic treatment in children…
Primary: To determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteersSecondary: To determine the safety of combined use of fosamprenavir with posaconazole in healthy vol-unteers
The primary objective of this study is to evaluate the PK of POS administered orally at three dosage levels to immunocompromised children with expected neutropenia (selected oncology patients, aplastic anemia patients and patients which undergo a…
• To assess feasibility and safety of a sequential treatment regime in which standard intensive chemotherapy (fludarabin-amsacrin-cytarabin) is directly followed by standard allogeneic stem cell transplantation (T cell depleted RIC alloSCT with…
The objectives of this study are to examine: (1) the long-term safety and efficacy of alemtuzumab in multiple sclerosis (MS) patients who received alemtuzumab during prior Genzyme-sponsored studies including CAMMS223, CAMMS323, or CAMMS32400507 (…
• To determine the pharmacokinetics of posaconazole (new solid oral and IV) given as prophylaxis to patients who are at risk for developing fungal infections after receiving conditioning therapy (except strictly non myeloablative (NMA)) for…
Both the Supera and the Absolute Pro Stent System are self-expandable stents that are frequently used in regular clinic practice in patients with obstructive vascular disease. Results of both stent systems have been evaluated in several studies and…
To evaluate the long-term safety and efficacy of alemtuzumab, for patients already treated with this medicine in preceding clinical trials (CARE-MS I, CARE-MS II and CAMMS03409).
Primary objective:To evaluate the efficacy, safety and tolerability of alemtuzumab intravenously (IV) in paediatric patients from 10 to <18 years of age with relapsing remitting multiple sclerosis (RRMS) who have disease activity on prior…
Primary objective:To determine the effect of obesity (BMI > 35 kg/m2) on the pharmacokinetics of posaconazole and develop a dosing regimen for obese patients. Secondary objective:• To describe the pharmacokinetics of the augmented dose of 400…
To deliver proof of concept that antifungal prophylaxis with posaconazole in addition to standard of care (SOC) can reduce the incidence of IAA in ICU patients with severe influenza, in comparison with SOC alone.To assess differences in cytokine…
The objective of this prospective, randomized study is to investigate the efficacy and safety of HSCT compared to the comparator group (alemtuzumab, cladribine or ocrelizumab) in patients with aggressive relapsing remitting MS. In Norway, the…
- In silico definition of the most optimal posaconazole dose for children and adolescents with CF aged 8 to 17 years.- Assess the prevalence of Aspergillus infection in children and adolescents with CF aged 8 -17 years.- An intensive sampling…