Optivate(Optivate) - 药物靶点：F10_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Factor VIII/von Willebrand factor (Bio Products Laboratory)

靶点

F10

作用机制

F10刺激剂(凝血因子X刺激剂)、凝血因子替代物

治疗领域

遗传病与畸形血液及淋巴系统疾病其他疾病

在研适应症-

非在研适应症

冯·维勒布兰德病

原研机构

Bio Products Laboratory USA, Inc.

在研机构-

非在研机构

Bio Products Laboratory USA, Inc.

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

4

项与 Optivate 相关的临床试验

NCT01051076 / CompletedN/AIIT

Immune Tolerance Induction Study in Patients With Severe Type A Haemophilia With Inhibitor After Failure of a Previous Induction of Immune Tolerance With FVII Concentrates Without Von Willebrand Factor Rescue

The purpose of this study is to evaluate whether a concentrate containing both FVIII and von Willebrand Factor (VWF) given at a high dose will induce immune tolerance in subjects who have already experienced and failed ITI with VWF-free FVIII concentrates. The treatment on this study is expected to last up to 33 months.

开始日期2009-11-03

申办/合作机构

City of Hope National Medical Center

[+4]

NCT00404300 / Terminated临床3期

An Open Multi-centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and Von Willebrand Factor Concentrate, in Patients With Von Willebrand Disease Who Are Undergoing Surgery

An open, multi-centre study in patients with von Willebrand Disease (VWD) undergoing surgery.

开始日期2007-02-01

申办/合作机构

Bio Products Laboratory USA, Inc.

EUCTR2006-000664-85-GB / Not yet recruiting临床3期

An Open Multi-centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and von Willebrand Factor Concentrate, in Patients with von Willebrand Disease who are Undergoing Surgery - A Study with OPTIVATE® in von Willebrand Disease Patients Who are Having Surgery

开始日期2006-12-19

申办/合作机构

Bio Products Laboratory USA, Inc.

100 项与 Optivate 相关的临床结果

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100 项与 Optivate 相关的转化医学

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100 项与 Optivate 相关的专利（医药）

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7

项与 Optivate 相关的文献（医药）

2019-01-01·Research and Practice in Thrombosis and Haemostasis

Evaluation of von Willebrand factor concentrates by platelet adhesion to collagen using an in vitro flow assay

Article

作者: Laffan, Mike ; Riddell, Anne ; McKinnon, Tom ; Gomez, Keith ; Vinayagam, Saravanan

BACKGROUNDVon Willebrand disease (VWD) results from quantitative or qualitative deficiency of von Willebrand factor (VWF) and is treated using VWF-containing concentrates. Several studies have compared the function of various VWF containing concentrates however this has not been performed using shear based assays.OBJECTIVESTo compare the platelet-capture potential of 10 commercially available, plasma-derived VWF concentrates under shear conditions.METHODSVWF containing concentrates were assessed for VWF:Ag, VWF:CB, VWF:RCo, factor VIII:C ADAMTS13 content, VWF multimeric profile and glycan content using lectin binding assays. Free-thiol content of each concentrate was investigated using MPB binding assays. An in vitro flow assay was used to determine the ability of each concentrate to mediate platelet capture to collagen.RESULTSVWF multimeric analysis revealed reduction of high molecular weight (HMW) forms in four of the concentrates (Alphante, Octanate and Haemoctin, and 8Y). The high MW multimer distribution of the remaining six concentrates (Optivate, Wilate, Fandhi, Wilfactin, Haemate P, and Voncento) was similar to the plasma control. Lectin analysis demonstrated that 8Y had increased amount of T-antigen. Although platelet capture after 5 minutes perfusion was similar for all concentrates; Alphante, Octanate, and Haemoctin, demonstrated the lowest levels of platelet capture after 60 seconds of perfusion. Free-thiol content and ADAMTS13 levels varied widely between the concentrates but was not correlated with function.CONCLUSIONAlphanate, Octanate, and Haemoctin, lacked HMW multimers and had the lowest initial platelet capture levels suggesting that the presence of VWF HMW multimers are required for initial platelet deposition.

2016-01-01·Haemophilia

Pharmacokinetic profile of Optivate^® (high‐purity factor VIII/von Willebrand factor concentrate) in treating von Willebrand disease

Letter

作者: Inbal, A. ; Dash, C. ; Shaikh‐Zaidi, R. ; Lubetsky, A.

2011-09-01·Haemophilia2区 · 医学

Clinical experience with Optivate^®, high‐purity factor VIII (FVIII) product with von Willebrand factor (VWF) in young children with haemophilia A

2区 · 医学

Article

作者: C. H. Dash ; A. Chybicka ; R. Shaikh-Zaidi ; M. Matysiak ; J. R. Kowalczyk ; K. Gillanders ; H. Bobrowska ; W. Balwierz

Summary. Optivate® is a high‐purity FVIII/VWF product. Its safety, tolerability and efficacy in subjects ≥12 years have been demonstrated. This study was undertaken to assess Optivate® in children with haemophilia A. Twenty‐five children, including one PUP (previously untreated patient), aged 1–6 years (mean 4.67 years) were treated with Optivate® for 26 weeks. Inhibitors were assessed every 3 months and viral status at the study start and end. Prophylaxis was used by five boys and on demand by twenty. The mean number of bleeds in the study was lower compared to the same period pre‐study (12.0/child vs. 16.2/child), with fewer bleeds (P < 0.05) in the prophylactic subgroup (8.0/child) compared with the on‐demand sub‐group (13.4/child). Fourteen major bleeds were reported, all by the on‐demand sub‐group. Children on prophylaxis were administered a mean of 59.4 infusions; on‐demand group 35.1 infusions. A total of 998 infusions were used with a mean dose of 29.1 IU kg−1, and a mean of 38.6 exposure days (ED). Children <4 years used higher doses, and reported fewer bleeds than older children. Children’s Parents/Guardians rated Optivate® as helpful or very helpful in controlling 97.5% of bleeds by the prophylactic group, and in 98.5% of the bleeds in the on‐demand group. Only 5 of 101 ADRs were treatment‐related events (5%), all were mild and non‐serious. There were no clinically significant changes in vital signs, viral transmissions or inhibitors. In young children Optivate® was well tolerated, safe and efficacious.

100 项与 Optivate 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
冯·维勒布兰德病	临床3期	英国	Bio Products Laboratory USA, Inc.	2006-11-01
冯·维勒布兰德病	临床3期	以色列	Bio Products Laboratory USA, Inc.	2006-11-01