Randomized, prospective double-blind placebo controlled study for the evaluation of the number, duration and severity of Upper Respiratory Tract Infections in children with risk of recurrence after standard treatment with bacterial lysates Paspat 3 mg tablets, over an observation period of six months. - ICASP (Infant Clinical Assessment Study on Paspat).

开始日期2016-07-06

申办/合作机构

Daiichi Sankyo Italia SpA

EUCTR2016-000978-38-IT / Not yet recruiting临床3期

Randomized, prospective double-blind placebo controlled study for the evaluation of the number, duration and severity of Respiratory Tract Infections in adults with risk of recurrence after standard treatment with bacterial lysates Paspat 3 mg tablets, over an observation period of six months. - ACASP

开始日期2016-07-06

申办/合作机构

Daiichi Sankyo Italia SpA

100 项与 Daiichi Sankyo Italia SpA 相关的临床结果

登录后查看更多信息

0 项与 Daiichi Sankyo Italia SpA 相关的专利（医药）

登录后查看更多信息

项与 Daiichi Sankyo Italia SpA 相关的文献（医药）

2023-11-02·Blood

Patient-Reported Outcomes in Acute Myeloid Leukemia Patients with FLT3-ITD Mutation Receiving Quizartinib Vs. Standard Chemotherapy: Results from the Quantum-First Trial

作者: Oliva, Esther Natalie ; Cortes, Jorge ; Unni, Sudhir ; Sekeres, Mikkael A. ; Vashi, Rohan ; Li, Xiaocong ; Cottone, Francesco

Introduction: QuANTUM-First (NCT02668653) is a multicenter, global, randomized, double-blind phase 3 clinical trial evaluating the efficacy and safety of the novel oral fms-like tyrosine kinase 3 inhibitor (FLT3i) quizartinib in combination with standard induction and consolidation chemotherapy, and as maintenance monotherapy for up to 36 cycles in patients 18-75 years old with FLT3-ITD positive acute myeloid leukemia (AML). Quizartinib demonstrated a clinically meaningful and statistically significant improvement in overall survival (OS) versus placebo. An exploratory endpoint of the trial was to assess the impact of quizartinib on patient-reported outcomes (PROs). This is the first report of the longitudinal results of the PRO measures (PROMs) collected in the QuANTUM-First trial.Methods: Patients were randomized to receive chemotherapy + quizartinib or chemotherapy + placebo. PROMs were the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30) and EuroQol EQ-5D-5L. Baseline measurement was collected on day 8 of the first induction cycle, and repeated measurements were collected on day 28 of induction cycles 1-2, day 6 and 28 of consolidation cycles 1-4, and day 1 of continuation cycles 1-34 at 3-cycle intervals. EORTC QLQ-C30 and EQ-5D-5L scores were calculated as per their respective scoring manuals and included mean (95% CI, p-value) score for each domain of the EORTC QLQ-C30 and EQ-5D-5L index score, as well as mean change from baseline score at each timepoint. A minimal clinically important difference (MCID) score ≥10 points for each domain of the EORTC QLQ-C30, was considered clinically meaningful. A mixed-effect model for repeated measures (MMRM) and time until definitive deterioration (TUDD) was used to assess the longitudinal impact of treatment on PROs. TUDD was defined as time from baseline PRO score to first deterioration of the score beyond the MCID as compared to the baseline without further improvement of more than one MCID as compared to the reference score or without any further available score.Results: A total of 509 out of 539 patients from the trial (254 quizartinib; 255 placebo) were included for PRO analysis. Patient compliance to questionnaire completion at the beginning of each phase was high and similar for both arms and most scales (Global Health Status [GHS] completion rate (%) on induction cycle 1, consolidation cycle 1, and continuation cycle 1: 99.2, 95.3, 93.4, respectively) Baseline PRO scores were comparable between arms and were lower than the general population norm EORTC QLQ-C30 and EQ-5D-5L scores for EU and US (Table 1). Per MMRM, there were clinically meaningful improvements from baseline in GHS (Figure 1) and fatigue in both arms. However, there was no significant difference between arms for the change from baseline score although placebo arm had numerically better scores specifically during the maintenance phase (treatment difference for quizartinib - placebo was -2.0 [95% CI: -4.8, 0.7], p=0.1479 for GHS and 3.0 [95% CI: -0.1, 6.1], p=0.0600 for fatigue). Similar trends towards clinically meaningful improvement in score over time for both arms and no significant differences between arms were observed in most of the functional and symptom scales of EORTC QLQ-C30 and EQ-5D-5L index scores. By TUDD analysis, quizartinib arm showed slower deterioration in several scales (specifically GHS, cognitive function, appetite loss, and constipation) but the differences did not reach statistical significance.Conclusions: QuANTUM-First is the first study to explore the impact of quizartinib on PROs. Quizartinib showed improvement in OS without any detrimental impact on quality of life and symptoms when added to standard chemotherapy followed by maintenance monotherapy in patients with newly diagnosed FLT3-ITD AML.

2022-10-03·European Heart Journal

Clinical outcomes in patients with atrial fibrillation with or without concomitant diabetes after two years of edoxaban treatment: ETNA-AF-Europe registry

作者: Patti, G ; Pecen, L ; Casalnuovo, G ; De Caterina, R ; Kirchhof, P

AbstractBackground/IntroductionConcomitant diabetes mellitus (DM) in patients with atrial fibrillation (AF) has been associated with a higher risk of stroke/systemic embolic events (SEE), and higher mortality.PurposeTo evaluate effectiveness and safety outcomes in AF patients with different types of concomitant DM vs those without concomitant DM after 2 years of edoxaban treatment in a sub-analysis of the prospective ETNA-AF-Europe registry.MethodsPatients with AF who received edoxaban once daily were enrolled across 825 centres in 10 European countries. This sub-analysis is based on a data snapshot from 26th October 2020. Patients were grouped by DM status (with or without DM; insulin-treated or non-insulin-treated DM). Baseline characteristics are summarised descriptively. Kaplan-Meier (KM) survival curves of outcomes were constructed; annualised event rates (AERs; %/year) and comparisons between patients with or without DM by univariate analysis are presented. Comparisons of patients with insulin- vs non-insulin-treated DM were made by multivariate analysis adjusted for HbA1c.ResultsPatients' demographics and baseline characteristics are shown in Table 1. Of 13,133 patients with AF, 2885 (22.0%) had DM. Among patients with DM, 2756 (95.6%) received treatment: 605 (22.0%) with insulin and 2151 (78.0%) with non-insulin treatments. KM curves for effectiveness and safety outcomes are shown in Figure 1. AERs (%/year) of ischaemic stroke/transient ischaemic attack (TIA)/SEE were 0.86% in patients with AF and no DM, 0.87% with non-insulin-treated DM (p=0.9216 vs no DM) and 1.81% with insulin-treated DM (p=0.0022 vs no DM; p=0.0014 vs non-insulin-treated DM). AERs of myocardial infarction (MI) were 0.40%, 0.43% (p=0.7454 vs no DM), and 1.04% (p=0.0033 vs no DM) respectively; of major bleeding were 0.90%, 1.10% (p=0.2427 vs no DM), and 1.71% (p=0.0106 vs no DM), respectively; and of all-cause death were 3.36%, 5.02% (p<0.0001 vs no DM), and 8.91% (p<0.0001 vs no DM) respectively. In a multivariate analysis of DM patients adjusted for HbA1c (patients with AF and DM with HbA1c measured, n=1869), patients with AF and insulin-treated DM had a higher risk of stroke/TIA/SEE (HbA1c adjusted HR [95% CI]: 2.13 [1.12–4.05], p=0.0205) and all-cause death (1.83 [1.35–2.49], p=0.0001) vs those with non-insulin-treated DM; no significant difference in the risk of MI (2.10 [0.78–5.66], p=0.1448) or major bleeding (1.81 [0.95–3.44], p=0.0706) was detected between the groups.ConclusionIn patients with AF and DM, risk of stroke/TIA/SEE, MI and major bleeding was confined to insulin-treated DM patients only. These patients also had poorer survival rates vs those without DM and those with non-insulin-treated DM, reinforcing previously published data showing a strong association between insulin treatment and poorer outcomes, and a mild/absent association between non-insulin treatments and poorer outcomes in patients with AF and DM.Funding AcknowledgementType of funding sources: Private company. Main funding source(s): This research was funded by Daiichi Sankyo Europe.

2018-11-01·Clinical Drug Investigation4区 · 医学

Safety of Edoxaban 30 mg in Elderly Patients with Severe Renal Impairment

4区 · 医学

Article

作者: Fazio, Giovanni ; Colonna, Paolo ; Gambacurta, Rosanna ; Dentamaro, Ilaria ; Alcamo, Pasquale

BACKGROUND AND OBJECTIVEPatients with atrial fibrillation (AF) and advanced chronic kidney disease (CKD) are at high risk of adverse events and are complicated to manage. There is little evidence on the effects of non-vitamin K oral anticoagulants in patients with severe CKD. Preliminary data in patients taking edoxaban whose creatinine clearance fell below 30 mL/min showed a low risk of stroke and major bleeding. The aim of our study is to test the safety of edoxaban 30 mg/day in patients with severe renal impairment with an estimated glomerular filtration rate (eGFR) of 15-29 mL/min.METHODSWe analyzed retrospective data from 46 patients who had documented AF with severe renal impairment (eGFR between 15 and 29 mL/min). The follow-up, characterized by clinical examination and blood analysis, was performed at 3, 6, and 12 months. The main endpoint was the incidence of major bleedings or clinically relevant non-major (CRNM) bleedings or thromboembolic events.RESULTSAt the time of the data collection, the average follow-up was 9.13 ± 3.0 months. There were no major bleedings, strokes, systemic embolisms, or cardiovascular deaths reported: one non-cardiac death and five minor hemorrhages occurred. No differences related to the severity of CKD were observed in the left ventricular ejection fraction at echocardiography and in the thrombotic and hemorrhagic risk profile.CONCLUSIONIn this explorative study analyzing patients with severe CKD treated with edoxaban 30 mg once daily, no major bleeding or thrombotic events were observed. Some minor bleedings were observed. While additional studies are necessary to confirm the results of this exploratory study, edoxaban 30 mg once daily appears to be safe in patients with severe CKD.

100 项与 Daiichi Sankyo Italia SpA 相关的药物交易

登录后查看更多信息

100 项与 Daiichi Sankyo Italia SpA 相关的转化医学

登录后查看更多信息