Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial

Borgwardt Line; Guffon Nathalie; Amraoui Yasmina; Dali Christine I.; De Meirleir Linda; Gil-Campos Mercedes; Heron Benedicte; Geraci Silvia; Ardigo Diego; Cattaneo Federica; Fogh Jens; Van den Hout J. M. Hannerieke; Beck Michael; Jones Simon A.; Tylki-Szymanska Anna; Haugsted Ulla; Lund Allan M.

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Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial

机译：Velmanase Alfa在治疗α-甘露糖苷的患者中的疗效和安全性：III期多期核和延伸阶段分析的结果，双盲，随机，安慰剂对照试验

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IntroductionThis phase III, double-blind, randomised, placebo-controlled trial (and extension phase) was designed to assess the efficacy and safety of velmanase alfa (VA) in alpha-mannosidosis (AM) patients.

机译：简介III，双盲，随机，安慰剂对照试验（和扩展阶段）旨在评估Velmanase Alfa（VA）在α-甘露糖苷中（AM）患者的疗效和安全性。

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来源
《Journal of inherited metabolic disease》 |2018年第6期|共9页
作者
Borgwardt Line; Guffon Nathalie; Amraoui Yasmina; Dali Christine I.; De Meirleir Linda; Gil-Campos Mercedes; Heron Benedicte; Geraci Silvia; Ardigo Diego; Cattaneo Federica; Fogh Jens; Van den Hout J. M. Hannerieke; Beck Michael; Jones Simon A.; Tylki-Szymanska Anna; Haugsted Ulla; Lund Allan M.;
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作者单位

Ctr Inherited Metab Dis Dept Paediat &

Adolescent Med Copenhagen Denmark;

Hop Femme Mere Enfant Ctr Reference Malad Hereditaires Metab Lyon France;

Univ Med Ctr Mainz Ctr Pediat &

Adolescent Med Villa Metab Mainz Germany;

Ctr Inherited Metab Dis Dept Paediat &

Adolescent Med Copenhagen Denmark;

Univ Ziekenhuis Paediat Neurol &

Metab Brussels Belgium;

Univ Cordoba CIBERObn Unidad Metab &

Invest Pediat Hosp Univ Reina Sofia IMIBIC Cordoba Spain;

UPMC Univ 06 Sorbonne Univ Reference Ctr Lysosomal Dis Trousseau Hosp APHP Dept Pediat Nerol;

Chiesi Farmaceutici SpA Parma Italy;

Chiesi Farmaceutici SpA Parma Italy;

Chiesi Farmaceutici SpA Parma Italy;

Zymenex AS Hillerod Denmark;

Erasmus MC Univ Med Ctr Sophia Childrens Hosp Ctr Lysosomal &

Metab Dis Dept Pediat Rotterdam;

Univ Med Ctr Inst Human Genet Mainz Germany;

Cent Manchester Univ Hosp NHS Fdn Trust Manchester Ctr Genom Med Manchester Lancs England;

Childrens Mem Hlth Inst Dept Paediat Nutr &

Metab Dis Warsaw Poland;

Copenhagen Univ Hosp Rigshosp Dept Occupat Therapy &

Physiotherapy Copenhagen Denmark;

Ctr Inherited Metab Dis Dept Paediat &

Adolescent Med Copenhagen Denmark;

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正文语种 eng
中图分类内分泌腺疾病及代谢病;
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1. Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial [J] . Borgwardt Line, Guffon Nathalie, Amraoui Yasmina, Journal of inherited metabolic disease . 2018,第6期

机译：Velmanase Alfa在治疗α-甘露糖苷的患者中的疗效和安全性：III期多期核和延伸阶段分析的结果，双盲，随机，安慰剂对照试验
2. Efficacy and safety of a combination herbal medicinal product containing Tropaeoli majoris herba and Armoraciae rusticanae radix for the prophylactic treatment of patients with respiratory tract diseases: A randomised, prospective, double-blind, placebo-controlled phase III trial [J] . FintelmannV., AlbrechtU., SchmitzG., Current medical research and opinion . 2012,第11期

机译：含有Tropaeoli majoris herba和Armoraciae Rustanae radix的中草药组合产品对呼吸道疾病患者的预防性治疗的有效性和安全性：一项随机，前瞻性，双盲，安慰剂对照的III期临床试验
3. Efficacy and safety of a combination herbal medicinal product containing Tropaeoli majoris herba and Armoraciae rusticanae radix for the prophylactic treatment of patients with respiratory tract diseases: A randomised, prospective, double-blind, placebo-controlled phase III trial [J] . FintelmannV., AlbrechtU., SchmitzG., Current medical research and opinion . 2012,第11期

机译：含有Hotapaioli Majoris Herba和Armoraciae Rusticanae的疗效和安全性的疗效和安全性用于预防呼吸道疾病患者的预防治疗：随机，前瞻性，双盲，安慰剂控制期III试验
4. A double-blind, randomized phase II trial of thesafety and immunogenicity of 26-valent group A streptococcus vaccine in healthy adults [C] . Shelly A. McNeil, Scott A. Halperin, Joanne M. Langley, Lancefield International Symposium on Streptococci and Streptococcal Diseases . 2006

机译：一种双盲，随机期II试验，对健康成人的26岁的26岁群体的疫苗疫苗
5. A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial of Fish Oil (Eicosapentaenoic Acid and Docosahexaenoic Acid) on Lung and Systemic Inflammation in Patients with Acute Lung Injury. [D] . Stapleton, Renee Doney. 2010

机译：鱼油（二十碳五烯酸和二十二碳六烯酸）对急性肺损伤患者的肺和全身炎症的II期，随机，双盲，安慰剂对照试验。
6. Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre double-blind randomised placebo-controlled trial [O] . Line Borgwardt, Nathalie Guffon, Yasmina Amraoui, -1

机译：Velmanase alfa治疗α-甘露糖苷病患者的疗效和安全性：III期多中心双盲随机安慰剂对照试验的核心和延伸期分析结果
7. Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial [O] . Line Borgwardt, Nathalie Guffon, Yasmina Amraoui, 2018

机译：Velmanase Alfa在治疗α-甘露糖苷患者中的疗效和安全性：III期多期一组，双盲，随机，安慰剂对照试验的核心和延伸阶段分析

Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial

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