A Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ciraparantag for Reversal of Anticoagulation in Healthy Adults

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ciraparantag for reversal of anticoagulation induced by different anticoagulant drugs in generally healthy adults as measured primarily by an automated coagulometer device.

开始日期2021-10-13

申办/合作机构

Perosphere Pharmaceuticals, Inc.

NCT03288454 / Completed临床2期

Phase 2 Placebo-Controlled, Single-Site, Single-Blind Study of Apixaban Reversal by Ciraparantag as Measured by WBCT

This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and safety of ciraparantag administered to healthy volunteers anticoagulated with apixaban measuring clotting times using Whole Blood Clotting Time (WBCT).

开始日期2017-08-30

申办/合作机构

Perosphere Pharmaceuticals, Inc.

NCT03172910 / Completed临床2期

Phase 2 Placebo-Controlled, Single-Site, Single-Blind Study of Rivaroxaban Reversal by Ciraparantag as Measured by WBCT

This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and safety of ciraparantag administered to healthy volunteers anticoagulated with rivaroxaban measuring clotting times using Whole Blood Clotting Time (WBCT).

开始日期2017-05-08

申办/合作机构

Perosphere Pharmaceuticals, Inc.

100 项与 Perosphere Pharmaceuticals, Inc. 相关的临床结果

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0 项与 Perosphere Pharmaceuticals, Inc. 相关的专利（医药）

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项与 Perosphere Pharmaceuticals, Inc. 相关的文献（医药）

2019-04-01·Seminars in Thrombosis and Hemostasis

A Novel Whole Blood Point-of-Care Coagulometer to Measure the Effect of Direct Oral Anticoagulants and Heparins

Article

作者: Zappe, Stefan ; Laulicht, Bryan ; Jiang, Xuan ; Ansell, Jack ; Bakhru, Sasha ; Chen, Lirong ; Steiner, Solomon

AbstractThe direct oral anticoagulants (DOACs) currently require no monitoring for routine therapy of atrial fibrillation or venous thromboembolism. Measurement of activity, however, may be important in patients with major and life-threatening bleeding, patients needing emergent surgery, in reversal situations, or in patients at high risk of bleeding or thrombosis due to underlying conditions. For these patients, a widely available and rapid turnaround assay would be optimal. To date, there is no such assay available, especially for the direct factor Xa inhibitors. This report describes the performance of a new, rapid turnaround, point-of-care (PoC) assay for measuring the activity of a range of anticoagulants, including DOACs and heparins, in emergency situations and for routine measurement in high-risk patients. Perosphere Technologies' PoC coagulometer is a handheld instrument that performs individual coagulation tests on samples of fresh whole blood (∼10 µL) with clotting activated by glass contact and endpoint determination performed by infrared spectroscopy. In preclinical studies using rats anticoagulated with therapeutic doses of edoxaban or enoxaparin, the PoC coagulometer showed a strong linear correlation between pharmacokinetic parameters and clotting time with edoxaban (r 2 = 0.994) and with enoxaparin (r 2 = 0.967). These preclinical results suggest that this PoC coagulometer would be ideal to assess the pharmacodynamic effects of anticoagulants and their reversal agents. The PoC bedside instrument delivers results within minutes and requires no more than a drop of whole blood. Studies are underway to confirm these results in humans and to further characterize the performance of the instrument.

2018-11-29·Blood

Ciraparantag Safely and Effectively Reverses Apixaban and Rivaroxaban in Age-Matched Healthy Volunteers As Measured By Whole Blood Clotting Time

作者: Bakhru, Sasha ; Steiner, Solomon ; Ansell, Jack ; Laulicht, Bryan

AbstractBackground: Ciraparantag is a small molecule drug candidate in clinical development as a reversal agent for the Xa direct oral anticoagulants (DOACs) and low molecular weight heparin (LMWH). In previous clinical trials, ciraparantag has shown complete and sustained reversal of the Xa DOAC, edoxaban, and the LMWH, enoxaparin, following a single intravenous (i.v.) bolus dose, as measured by whole blood clotting time (WBCT) [1-3].Clinical Design: In the current studies, healthy subjects age-matched to the patient population, 50 to 75 years old, were administered either 10 mg apixaban p.o. BID for 3.5 days or 20 mg rivaroxaban p.o. QD for 3 days to steady-state. At maximal activity, either four hours after the third daily dose of rivaroxaban or three hours after the seventh twice daily dose of apixaban subjects were randomized 3:1::active:placebo in 16 subject dosing cohorts of 50 mg, 100 mg, 200 mg or 300 mg intravenous ciraparantag acetate, or placebo saline. Pharmacodynamic response was measured by WBCT, a modernized and standardized Lee White clotting time, in which the time for freshly drawn venous whole blood to clot after activation in glass test tubes maintained at physiologic temperature is measured by blinded observers.Results and Discussion: The safety profile of ciraparantag in these studies is consistent with previous trials. The most common potentially related adverse events were transient mild facial flushing and dysgeusia. No pro-coagulant signals were observed in any clinical trials to date. Doses of 100 mg and higher showed complete and sustained reversal of both steady-state apixaban (Figure 1a) and rivaroxaban (Figure 1b). Ciraparantag acetate doses of 100 mg and higher have demonstrated complete and sustained reversal of apixaban, edoxaban, enoxaparin and rivaroxaban potentiating a single reversal dose strategy for the Xa DOACs and LMWH.Figure 1: Ciraparantag acetate shows complete and sustained reversal of steady-state apixaban (a) and rivaroxaban (b) at doses of 100 mg and greater, as measured by whole blood clotting time (WBCT).References Ansell JE, Bakhru SH, Laulicht BE, Steiner SS, Grosso MA, Brown K, Dishy V, Lanz HJ, Mercuri MF, Noveck RJ, Costin JC. "Single-dose ciraparantag safely and completely reverses anticoagulant effects of edoxaban." Thromb Haemost. 2017 Jan 26;117(2):238-245. Ansell JE, Laulicht BE, Bakhru SH, Hoffman M, Steiner SS, Costin JC. "Ciraparantag safely and completely reverses the anticoagulant effects of low molecular weight heparin." Thromb Res. 2016 Oct;146:113-118. Ansell JE, Bakhru SH, Laulicht BE, Steiner SS, Grosso M, Brown K, Dishy V, Noveck RJ, Costin JC. "Use of PER977 to reverse the anticoagulant effect of edoxaban." N Engl J Med. 2014 Nov 27;371(22):2141-2.Figure 1 Figure 1.DisclosuresLaulicht: Perosphere Pharmaceuticals Inc.: Employment, Equity Ownership, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties: US9522892B2. Bakhru:Perosphere Pharmaceuticals Inc.: Patents & Royalties: US9522892B2. Steiner:Perosphere Pharmaceuticals Inc.: Employment, Equity Ownership, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties: US9522892B2. Ansell:Perosphere Pharmaceuticals Inc.: Consultancy, Membership on an entity's Board of Directors or advisory committees.

项与 Perosphere Pharmaceuticals, Inc. 相关的新闻（医药）

2022-07-18

·PRNewswire

Anticoagulant Reversal Drug Market to attain value of US$ 2 Bn by 2026, TMR Study

Key role of pharma companies to fill gaps in terms of launch of precise drugs, NATP status for specific drugs, and meet unfulfilled clinical requirements to stir global market for anticoagulant reversal drugs FDA approval of AndeXXa for factor Xa inhibitors strongly influences growth of North America anticoagulant reversal drugs market WILMINGTON, Del., July 18, 2022 /PRNewswire/ -- Analysts at TMR estimate the anticoagulant reversal drugs market to expand at a CAGR of 15.6% during the forecast period from 2018 to 2026. Increasing incidence of atrial fibrillation among the expanding older population, increase in incidence of intracranial haemorrhage and gastrointestinal haemorrhage, and growing number of warfarin therapy that requires reversal agents are some key factors propelling the anticoagulant reversal drugs market. Substantial use of vitamin K for reversal of warfarin anticoagulation therapy is creating ample opportunities in anticoagulant reversal drugs market. Significant demand for anticoagulant reversal drugs for the growing number of warfarin therapy administered for blood clotting due to accidents, medical conditions fuels the growth of anticoagulant reversal drugs market. Increasing focus of anticoagulant reversal drugs manufacturers to develop precise drugs for reversal of action of anticoagulants, provide new technology add-on payment (NTAP) status to specific drugs, and meet unfulfilled clinical requirements owing to absence of specific drugs for anticoagulant reversal benefits the anticoagulant reversal drugs market. Request Brochure of Anticoagulant Reversal Drugs Market Research Report – Anticoagulant Reversal Drugs Market – Key Findings of the Report Increasing incidence of cardiac disorders, gastrointestinal haemorrhage, and intracranial haemorrhage is creating demand for anticoagulant reversal drugs world over Vitamin K product segment led the anticoagulant reversal drugs market in 2017. Increasing use of vitamin K for reversal of warfarin anticoagulation therapy is the primary factor fuelling the product segment. Leaning for vitamin K for treatment of warfarin associated haemorrhage in the U.S. strengthens the growth of vitamin K product segment. AndeXXa is anticipated to emerge as significant product segment in the anticoagulant reversal drugs market in the upcoming years. Recognition of AndeXXa as the first approved drug for the reversal effect of factor Xa inhibitors provides impetus to AndeXXa product segment. Estimations of large number of hospital admissions that will require antidote for factor Xa inhibitors to provide impetus to AndeXXa product segment. Prospects of new product approvals for factor Xa inhibitors to create growth opportunities in the anticoagulant reversal drugs market Hospital pharmacies distribution channel segment led the anticoagulant reversal drugs market in 2017 and the trend is anticipated to continue during the forecast period. Leaning of manufacturing companies to supply anticoagulant drugs to hospital pharmacies for maximum sales fuels the growth of hospital pharmacies distribution channel anticoagulant reversal drugs market. Led by the U.S., North America dominated the anticoagulant reversal drugs market in 2017. FDA approval for AndeXXa with a high target population for the drug in the U.S. strengthens growth of North America anticoagulant reversal drugs market. Robust clinical trials for FDA approval for first-time anticoagulant reversal drugs is a key growth strategy of leading players in the anticoagulant reversal drugs market Request for Analysis of COVID-19 Impact on Anticoagulant Reversal Drugs Market – Anticoagulant Reversal Drugs Market – Growth Drivers Critical role of reversal agents to counter the effects of anticoagulants in life-threatening situations drives the anticoagulant reversal drugs market Clinical use of anticoagulant reversal drugs for increasing incidence of intracranial haemorrhage, gastrointestinal haemorrhage, and cardiac disorders stimulates growth Get Exclusive PDF Sample Copy of Anticoagulant Reversal Drugs Market Report – Anticoagulant Reversal Drugs Market – Key Players Some of the key players operating in the anticoagulant reversal drugs market are; Pfizer Inc. Amneal Pharmaceuticals Inc. CSL Limited Perosphere Pharmaceuticals Inc. Octapharma AG Bausch Health Companies Inc. Fresenius Kabi AG Boehringer Ingelheim GmbH Portola Pharmaceuticals Inc. Make an Enquiry Before Buying – The anticoagulant reversal drugs market is segmented as follows; Anticoagulant Reversal Drugs Market, by Product Prothrombin Complex Concentrates Vitamin K Protamine Tranexmic Acid Idarucizumab Andexxa Others Anticoagulant Reversal Drugs Market, by Distribution Channel Hospital Pharmacies Retail Pharmacies Others Anticoagulant Reversal Drugs Market, by Region North America Europe Asia Pacific Latin America Middle East & Africa Modernization of healthcare in terms of both infrastructure and services have pushed the healthcare industry to new heights, Stay Updated with Latest Healthcare Research Reports by Transparency Market Research: CINV Existing and Pipeline Drugs Market: The global CINV existing and pipeline drugs market is expected to surpass value of US$ 3.2 Bn by the end of 2031. Antihypertensive Drugs Market: The global antihypertensive drugs market is anticipated to reach more than US$ 40 Bn by the end of 2031. Erectile Dysfunction (ED) Drugs Market: The global erectile dysfunction (ED) drugs market is expected to reach the value of US$ 2.5 Bn by the end of 2028. Oral Transmucosal Drugs Market: The global oral transmucosal drugs market was valued over US$ 14 Bn in 2020 and is projected to expand at a CAGR of ~6% from 2021 to 2031. Veterinary Dermatology Drugs Market: The global veterinary dermatology drugs market was valued over US$ 3.6 Bn in 2020 and is projected to expand at a moderate CAGR from 2021 to 2031. Respiratory Virus Infection Drugs Market: The respiratory virus infection drugs market is expected to surpass a value of US$ 82.4 Bn by the end of 2030. Hydroxychloroquine Drugs Market: The hydroxychloroquine drugs market is predicted to clock a robust CAGR of 10% during the forecast period. The global hydroxychloroquine drugs market is expected to cross US$ 1.9 Bn by 2030. Depression Drugs Market: The global depression drugs market is expected to attain a market value of US$ 24.3 Bn by the end of 2030. About Transparency Market Research Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyze information. Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports. For More Research Insights on Leading Industries, Visit Our YouTube Channel and hit subscribe for Future Update - Contact : Rohit Bhisey Transparency Market Research Inc. CORPORATE HEADQUARTER DOWNTOWN, 1000 N. West Street, Suite 1200, Wilmington, Delaware 19801 USA Tel: +1-518-618-1030 USA – Canada Toll Free: 866-552-3453 Website: Blog: Email: [email protected] Logo: SOURCE Transparency Market Research

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药物(靶点)	适应症	全球最高研发状态

Ciraparantag ( factor Xa )	-	临床2期
超速效赖脯胰岛素生物类似药(Perosphere, Inc.) ( INSR )	1型糖尿病更多	终止
PER-922 ( Heparin )	溃疡性结肠炎更多	无进展
PER-923 ( Heparin )	糖尿病足更多	无进展
PER-1080	超敏反应更多	无进展