伏帕尼酶(Vonapanitase) - 在研适应症：血管疾病_专利_临床

概要

基本信息

药物类型

酶

别名

Recombinant-human-type-I-pancreatic-elastase、Vonapanitase (USAN/INN)

+ [2]

靶点-

作用机制

ECM调节剂(细胞外基质蛋白调节剂)

治疗领域

心血管疾病

在研适应症

血管疾病

非在研适应症

慢性肾病外周动脉闭塞性疾病

原研机构

Proteon Therapeutics, Inc.

在研机构

Proteon Therapeutics, Inc.Qsv Pharma

非在研机构

ArTara Subsidiary, Inc.

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (美国)

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序列信息

Sequence Code 1158664

来源: *****

关联

8

项与伏帕尼酶相关的临床试验

NCT02956993 / Completed临床1期

A Phase 1, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of Vonapanitase Administered Following Angioplasty of a Distal Popliteal, Tibial or Peroneal Artery in Patients With Peripheral Artery Disease

The research study is designed to assess the technical feasibility and safety of a perivascular injection of vonapanitase delivered via micro-infusion catheter to the distal popliteal, tibial or peroneal arteries immediately following successful angioplasty.

开始日期2016-11-01

申办/合作机构

Proteon Therapeutics, Inc.

NCT02414841 / Completed临床3期

Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Vonapanitase is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether vonapanitase when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.

开始日期2015-08-01

申办/合作机构

Proteon Therapeutics, Inc.

NCT02110901 / Completed临床3期

Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.

开始日期2014-07-01

申办/合作机构

Proteon Therapeutics, Inc.

100 项与伏帕尼酶相关的临床结果

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100 项与伏帕尼酶相关的转化医学

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100 项与伏帕尼酶相关的专利（医药）

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10

项与伏帕尼酶相关的文献（医药）

2022-03-01·The Journal of Vascular Access4区 · 医学

PATENCY-2 trial of vonapanitase to promote radiocephalic fistula use for hemodialysis and secondary patency

4区 · 医学

Article

作者: Teruya, Theodore H ; Wilson, Samuel E ; Mishler, Rick E ; Magill, Missy ; Lindow, Francesca ; Peden, Eric K ; Browne, Barry J ; Ferris, Brian L ; Dixon, Bradley S ; Ozaki, Charles Keith ; Gustafson, Pamela ; Settle, Stephen M ; Burke, Steven K ; Wong, Marco D ; Hendon, Kendra S ; Scavo, Vincent A ; Bleyer, Anthony J ; Moist, Louise ; Lucas, John F

Objective: Arteriovenous fistulas created for hemodialysis often fail to become usable and are frequently abandoned. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in increasing radiocephalic fistula use for hemodialysis and secondary patency. Methods: PATENCY-2 was a randomized, double-blind, placebo-controlled trial in patients on or approaching the need for hemodialysis undergoing radiocephalic arteriovenous fistula creation. Of 696 screened, 613 were randomized, and 603 were treated (vonapanitase n = 405, placebo n = 208). The study drug solution was applied topically to the artery and vein for 10 min immediately after fistula creation. The primary endpoints were fistula use for hemodialysis and secondary patency (fistula survival without abandonment). Other efficacy endpoints included unassisted fistula use for hemodialysis, primary unassisted patency, fistula maturation and unassisted maturation by ultrasound criteria, and fistula procedure rates. Results: The proportions of patients with fistula use for hemodialysis was similar between groups, 70% vonapanitase and 65% placebo, ( p = 0.33). The Kaplan–Meier estimates of 12-month secondary patency were 78% (95% confidence interval [CI], 73–82) for vonapanitase and 76% (95% CI, 70–82) for placebo ( p = 0.93). The proportions with unassisted fistula use for hemodialysis were 46% vonapanitase and 37% placebo ( p = 0.054). The Kaplan–Meier estimates of 12-month primary unassisted patency were 50% (95% CI, 44–55) for vonapanitase and 43% (95% CI, 35–50) for placebo ( p = 0.18). There were no differences in the proportion of patients with fistula maturation or in fistula procedure rates. Adverse events were similar between groups. Vonapanitase was not immunogenic. Conclusions: Vonapanitase treatment did not achieve clinical or statistical significance to meaningfully improve radiocephalic fistula surgical outcomes. Outcome in the placebo group were better than in historical controls. Vonapanitase was well-tolerated and safe. TRIAL REGISTRATION: clinicaltrials.gov: NCT02414841 ( https://clinicaltrials.gov/ct2/show/NCT02414841 )

2019-02-01·Journal of Vascular Surgery2区 · 医学

A randomized trial of vonapanitase (PATENCY-1) to promote radiocephalic fistula patency and use for hemodialysis

2区 · 医学

Article

作者: Peden, Eric K ; Mishler, Rick ; Ozaki, C Keith ; Scavo, Vincent A ; Lee, Timmy ; Browne, Barry J ; Burke, Steven K ; Kidd, Kendrah ; Bleyer, Anthony J ; O'Connor, Timothy P ; Dixon, Bradley S ; Wilson, Samuel E ; Ferris, Brian L

OBJECTIVEArteriovenous fistulas created in patients with chronic kidney disease often lose patency and fail to become usable. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in promoting radiocephalic fistula patency and use for hemodialysis.METHODSPATENCY-1 was a double-blind, placebo-controlled trial that enrolled 349 patients on or approaching hemodialysis and being evaluated for radiocephalic arteriovenous fistula creation. Of these, 313 were randomized and 311 treated. Patients were assigned to vonapanitase (n = 210) or placebo (n = 103). The study drug solution was applied topically to the artery and vein for 10 minutes immediately after fistula creation. The primary and secondary end points were primary patency (time to first thrombosis or corrective procedure) and secondary patency (time to abandonment). Tertiary end points included use of the fistula for hemodialysis, fistula maturation by ultrasound, and procedure rates.RESULTSThe Kaplan-Meier estimates of 12-month primary patency were 42% (95% confidence interval [CI], 35-49) and 31% (95% CI, 21-42) for vonapanitase and placebo (P = .25). The Kaplan-Meier estimates of 12-month secondary patency were 74% (95% CI, 68-80) and 61% (95% CI, 51-71) for vonapanitase and placebo (P = .048). The proportions of vonapanitase and placebo patients were 39% and 25% (P = .035) with unassisted use for hemodialysis and 64% and 44% (P = .006) with unassisted plus assisted use.CONCLUSIONSVonapanitase treatment did not significantly improve primary patency but was associated with increased secondary patency and use for hemodialysis. Further research is needed to evaluate these end points.

2017-04-01·Journal of Vascular Surgery2区 · 医学

Arteriovenous fistula patency in the 3 years following vonapanitase and placebo treatment

2区 · 医学

Article

作者: Sam, Albert D ; Schanzer, Andres S ; Peden, Eric K ; Dixon, Bradley S ; Browne, Barry J ; O'Connor, Timothy P ; Burke, Steven K ; Jensik, Stephen C

OBJECTIVEThis study explored the long-term outcomes of arteriovenous fistulas treated with vonapanitase (recombinant human elastase) at the time of surgical creation.METHODSThis was a randomized, double-blind, placebo-controlled trial of 151 patients undergoing radiocephalic or brachiocephalic arteriovenous fistula creation who were randomized equally to placebo, vonapanitase 10 μg, or vonapanitase 30 μg. The results after 1 year of follow-up were previously reported. The current analysis occurred when the last patient treated was observed for 3 years. For the current analysis, the primary end point was primary patency; the secondary end points included secondary patency, use of the fistula for hemodialysis, and rate of procedures to restore or to maintain patency.RESULTSThere was no significant difference in the risk of primary patency loss with vonapanitase 10 μg or 30 μg vs placebo. When seven initial patency loss events related to cephalic arch and central vein balloon angioplasty were excluded, the risk of patency loss was reduced with vonapanitase overall (hazard ratio [HR], 0.63; P = .049) and 30 μg (HR, 0.51; P = .03). In patients with radiocephalic fistulas (n = 67), the risks of primary and secondary patency loss were reduced with 30 μg (HR, 0.37 [P = .02] and 0.24 [P = .046], respectively). The rate of procedures to restore or to maintain fistula patency was reduced with 30 μg vs placebo (0.23 vs 0.72 procedure days/patient/year; P = .03) and also reduced in patients with radiocephalic fistulas with 30 μg vs placebo (0.17 vs 0.85 procedure days/patient/year; P = .048).CONCLUSIONSIn this study, vonapanitase did not significantly improve primary patency in the primary analysis but did significantly improve primary patency in an analysis that excluded patency loss due to cephalic arch and central vein balloon angioplasty. In patients with radiocephalic fistulas, 30 μg significantly improved primary and secondary patency. Vonapanitase 30 μg decreased the rate of procedures to restore or to maintain patency in the analysis that included all patients and in the subset with radiocephalic fistulas.

100 项与伏帕尼酶相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11770	-	-	DB11690

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
血管疾病	临床3期	-	Qsv Pharma	-
血管疾病	临床3期	-	Proteon Therapeutics, Inc.	-
外周动脉闭塞性疾病	临床2期	美国	Proteon Therapeutics, Inc.	2012-10-01
慢性肾病	药物发现	美国	Proteon Therapeutics, Inc.	2014-07-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02414841 (PATENCY-2, Pubmed \| J Vasc Access) 人工标引	临床3期	-	613	Vonapanitase	鏇襯獵範鏇網壓鬱壓鬱(觸淵範齋壓繭鏇鹹鑰構) = 憲選廠積鏇鹽壓醖製鑰醖範餘觸糧衊膚廠製齋 (齋醖鏇鏇願網膚選膚築 ) 更多	不佳	2021-01-22
				Placebo	鏇襯獵範鏇網壓鬱壓鬱(觸淵範齋壓繭鏇鹹鑰構) = 淵蓋觸積壓齋憲製鹽觸醖範餘觸糧衊膚廠製齋 (齋醖鏇鏇願網膚選膚築 ) 更多
NCT02414841 (PATENCY-2, CTgov)	临床3期	慢性肾病	696	Vonapanitase (Vonapanitase)	糧築網壓鏇選製窪鹽構(範獵鑰鹽壓製蓋襯顧鹽) = 獵廠艱願觸獵齋齋餘鏇遞繭窪壓觸鑰膚願夢糧 (鏇遞範網襯憲壓範構醖, 築網淵遞夢壓醖蓋餘鬱 ~ 製齋齋鏇構構醖餘餘積) 更多	-	2019-08-13
				Placebo (Placebo)	糧築網壓鏇選製窪鹽構(範獵鑰鹽壓製蓋襯顧鹽) = 餘鏇遞鏇選齋積繭艱積遞繭窪壓觸鑰膚願夢糧 (鏇遞範網襯憲壓範構醖, 壓願衊積網獵蓋憲繭鑰 ~ 鑰艱網簾築廠獵選壓壓) 更多
NCT02110901 (PATENCY-1, CTgov)	临床3期	慢性肾病	349	Placebo	壓餘鹽壓膚壓鹹選窪衊(鬱網範選鑰糧夢夢憲獵) = 鹹願繭衊獵蓋觸夢簾糧獵獵糧齋襯簾繭鬱積鏇 (襯壓壓壓構構窪鹹襯網, 顧獵蓋淵製齋餘築製獵 ~ 選廠繭鏇衊構衊蓋獵遞) 更多	-	2019-07-09
NCT02110901 (PATENCY-1, Pubmed) 人工标引	临床3期	慢性肾病	313	vonapanitase	廠夢獵簾餘遞廠鏇鹹積(鑰遞淵蓋憲觸範鑰憲壓) = 糧範壓艱繭憲鏇鹹壓鏇壓構鏇膚壓觸繭選遞觸 (衊鑰獵構選鬱鹹鹽選遞, 35 ~ 49) 更多	不佳	2019-02-01
				Placebo	廠夢獵簾餘遞廠鏇鹹積(鑰遞淵蓋憲觸範鑰憲壓) = 簾糧餘鑰鏇遞觸積鑰繭壓構鏇膚壓觸繭選遞觸 (衊鑰獵構選鬱鹹鹽選遞, 21 ~ 42) 更多
NCT02110901 (ASN2017)	临床3期	慢性肾病	311	Vonapanitase	齋艱憲獵鬱顧鹽遞積膚(獵築鹽艱窪蓋膚鹽鏇窪) = 夢醖範淵鹽蓋餘獵願遞顧鑰窪壓糧鏇築醖鹹醖 (鹹憲築構網醖範襯鏇淵 ) 更多	积极	2017-10-31
				Placebo	齋艱憲獵鬱顧鹽遞積膚(獵築鹽艱窪蓋膚鹽鏇窪) = 壓觸蓋積艱簾醖膚憲艱顧鑰窪壓糧鏇築醖鹹醖 (鹹憲築構網醖範襯鏇淵 ) 更多
NCT01305824 (Pubmed \| J Vasc Surg)	临床2期	动静脉瘘	151	Placebo	簾築構餘鹹窪壓選壓製(醖壓構窪繭壓網餘艱襯) = 膚觸鑰窪鹽廠廠構艱齋憲膚顧築齋網簾淵鹹醖 (範壓淵網壓淵窪遞壓觸 )	积极	2014-08-01
				PRT-201 10 μg	簾築構餘鹹窪壓選壓製(醖壓構窪繭壓網餘艱襯) = 廠繭鹹積醖築選觸鏇憲憲膚顧築齋網簾淵鹹醖 (範壓淵網壓淵窪遞壓觸 )