SHEPHERD is an open-label, non-randomized, non-placebo- controlled, multi-center clinical study, primarily aimed at generating safety data with eculizumab in a broader population of hemolytic PNH patients with a history of transfusion. a) the sum of the number of deaths observed among eculizumab patients in the 26-week controlled TRIUMPH trial (no deaths), the 52-week uncontrolled SHEPHERD study (one death), the 12-week uncontrolled PILOT study (no deaths) and the 2-year E05-001 (2 deaths); and Further analysis of results from the three studies earlier (phase II pilot study, TRIUMPH and SHEPHERD trials) revealed that eculizumab treatment led to a ~ 13-fold reduction in the rate of thromboembolism in PNH patients and a ~ 17-fold decrease in patients treated with antithrombotics [306]. The secondary objectives of that study were to analyze hemolysis reduction as measured by LDH AUC and changes in the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) QoL scale. The SHEPHERD study was designed to evaluate the safety and efficacy of eculizumab in PNH patients by relaxing the inclusion criteria of the previous randomized, placebo-controlled TRIUMPH study,7 to allow patients with minimal transfusion support and evidence of thrombocytopenia to participate. Patients enrolled in the SHEPHERD study received the same eculizumab dosing regimen as used in the TRIUMPH study. Following the 26 weeks of treatment, there was an 8‐ to 12‐week post‐treatment follow‐up period. The pre-specified primary endpoints of the trial were safety and a reduction in intravascular hemolysis as measured by the surrogate endpoint lactate dehydrogenase (LDH). After initiation of the TRIUMPH study, eculizumab was evaluated in SHEPHERD, an open-label, non-placebo controlled, phase 3 clinical safety and efficacy study in a … The study drug and placebo for the treatment period were supplied by Alexion Pharmaceuticals, Inc., Cheshire, CT. The primary objective of SHEPHERD is safety, and efficacy measures will also be obtained. In a 3rd, open-label study (Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-centre Open-label Research Design Study [SHEPHERD]), Brodsky et al (2008) examined the safety and effectiveness of eculizumab in 97 subjects who had received at least 1 transfusion in the prior 24 months and with at least 30,000 platelets/microliter. SHEPHERD was an open-label, global Phase III study in which patients received eculizumab for 52 weeks. Values from the pilot study were normalized to that of the TRIUMPH and SHEPHERD studies and include data from the subsequent one-year extension study. Patients and study design -SHEPHERD SHEPHERD (Safety in Haemolytic PNH Patients Treated withEculizumab; A Multi-center Open-label Research Design Study) was an open-label, clinical study designed to investigate the long-term safety and efficacy of eculizumab (Brodsky et al, 2008). The primary objective of the SHEPHERD study was to evaluate the safety of eculizumab in patients with transfu-sion-dependent PNH. SHEPHERD (Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study) encompassed a broader PNH …
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