ISIS-329993(ISIS-329993) - 药物靶点：CRP_在研适应症：心房颤动_专利_临床

概要

基本信息

药物类型

反义寡核苷酸

别名

ISIS CRPRx、ISIS-CRP、ISIS-CRPRx

靶点

CRP

作用机制

CRP抑制剂(C-反应蛋白抑制剂)

治疗领域

心血管疾病

在研适应症

心房颤动

非在研适应症-

原研机构

Ionis Pharmaceuticals, Inc.

在研机构

Ionis

非在研机构

Ionis Pharmaceuticals, Inc.

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 525307812

关联

2

项与 ISIS-329993 相关的临床试验

NCT01710852 / Completed临床2期

A Phase 2 Study to Assess the Antiarrhythmic and Symptomatic Effect of the Second Generation Antisense Oligonucleotide ISIS 329993 Targeting CRP in Patients With Paroxysmal Atrial Fibrillation

The purpose of this study is to evaluate whether treatment with ISIS CRP Rx can reduce AF (Atrial Fibrillation) burden (percentage of time spent in AF) in subjects with paroxysmal AF

开始日期2012-10-01

申办/合作机构

Ionis Pharmaceuticals, Inc.

EUCTR2012-000833-38-GB / Not yet recruiting临床2期

A Phase 2 Study to Assess the Antiarrhythmic and Symptomatic Effect of the Second Generation Antisense Oligonucleotide ISIS 329993 Targeting CRP in Patients with Paroxysmal Atrial Fibrillation - 329993-CS6, Original

开始日期2012-06-19

申办/合作机构-

100 项与 ISIS-329993 相关的临床结果

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100 项与 ISIS-329993 相关的转化医学

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100 项与 ISIS-329993 相关的专利（医药）

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24

项与 ISIS-329993 相关的文献（医药）

2024-05-01·Revista espanola de cirugia ortopedica y traumatologia

Experiencia en complicaciones mayores con las prótesis totales trapeciometacarpianas

Article

作者: Ayala-Gutiérrez, H ; Sánchez-Crespo, M R ; Del Canto-Alvarez, F J ; Couceiro-Otero, J ; Holgado-Fernández, M

INTRODUCTION:

The treatment of rhizarthrosis using trapeziometacarpal prostheses (TMP) is increasing. Complications may lead to loss of the implant and result in salvage surgery. Our aim was to assess major complications with the use of some TMP models and their rescue.

MATERIAL AND METHOD:

Retrospective study on TMP implanted between 2006 and 2021. Models studied: Arpe®, Elektra®, Ivory®, Maïa®, Isis® and Touch®. Demographic data were assessed, implant placement by radiographic study, technical data, complications, salvage surgeries and final survival.

RESULTS:

Review of 224 TMP, 45 Arpe® (95.5% survival, rate follow-up [R] 6-16 years), 5 Elektra® (80% survival, R 13-14), 14 Ivory® (92.8% survival, R 9-11), 7 Maïa® (100% survival, R 8-9), 115 Isis® (99.1% survival, R 1-8), 38 Touch® (100% survival, R 1-4). The medial angle of the dome with the proximal articular surface of the trapezium in the lateral plane, was: Arpe®: 8.85°, Elektra®: not assessable, Ivory®: 6.6°, Maïa®: 14.4°, Isis®: 3.8°, and Touch®: 5.95°. The Isis® was placed 100% with scopic guidance presenting a significantly lower angle respect to the medial angle of the dome with the proximal articular surface of the trapezium. As main complications, we observed 3.5% of dislocations and 4% of mobilisations, with the Elektra® being responsible for 47% of these. Nineteen salvage surgeries were performed, with 3% of the implants being lost.

CONCLUSIONS:

Dislocation and mobilisation are the most observed complications, the Elektra® responsible for almost half of them. Correct placement and implant design appear to be crucial to avoid them in the short and long term.

2015-06-01·Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing4区 · 医学

4区 · 医学

Article

作者: Steve Furniss ; Conn Sugihara ; Neil Sulke ; Nick Freemantle ; Steven G. Hughes

PURPOSE:

C-reactive protein (CRP) is known to be strongly associated with atrial fibrillation (AF). However, it is not clear if CRP is a causal factor for AF. ISIS-CRPRx is a novel antisense oligonucleotide that reduces CRP production by specifically inhibiting mRNA translation. The effect of ISIS-CRPRx on AF was evaluated.

METHODS:

A double-blind phase II trial of ISIS-CRPRx in patients with paroxysmal AF and DDDRP permanent pacemakers (PPMs) with advanced atrial and ventricular Holters allowing beat-to-beat arrhythmia follow-up.

RESULTS:

Twenty six patients were screened and seven patients dosed with ISIS-CRPRx. After 4 weeks of baseline assessment, patients were randomly assigned to two treatment periods of either placebo then ISIS-CRPRx or ISIS-CRPRx then placebo. All patients were followed up for 8 weeks after the active treatment period. There was a 63.7 % (95 % CI 38.4 to 78.6 %, p = 0.003) relative reduction in CRP on treatment with ISIS-CRPRx versus baseline. Sensitivity analyses demonstrated a consistent treatment effect. The primary end-point was change in AF burden assessed by PPM. There was no significant difference in AF burden on treatment with ISIS-CRPRx versus baseline (OR 1.6, 95 % CI -2.42 to 5.62, p = 0.37). ISIS CRPRx was safe and well tolerated and there were no serious adverse events.

CONCLUSIONS:

Treatment with ISIS-CRPRx did not reduce AF burden in patients with paroxysmal AF and PPMs, despite a large relative reduction in CRP. In this population, highly specific CRP reduction had no clinically discernable effect upon paroxysmal AF. However, average levels of CRP at baseline were relatively low, so it remains possible that AF patients with higher levels of CRP may benefit from CRP-directed therapy.

100 项与 ISIS-329993 相关的药物交易

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