Equine F(ab')2 antivenom(Instituto Bioclon)(Equine F(ab')2 antivenom(Instituto Bioclon))

概要

基本信息

药物类型

抗毒素

别名-

靶点-

作用机制-

治疗领域

神经系统疾病心血管疾病呼吸系统疾病+ [1]

在研适应症-

非在研适应症

腹痛腹泻水肿+ [7]

原研机构

Instituto Bioclon SA de CV

在研机构-

非在研机构

Instituto Bioclon SA de CV

最高研发阶段无进展临床2/3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

2

项与 Equine F(ab')2 antivenom(Instituto Bioclon) 相关的临床试验

ChiCTR2300069623 / Completed临床1期IIT

A single-center, randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of a single dose of F(ab')2 antivenom of Daboia russelii siamensis in Chinese healthy subjects

开始日期2020-12-28

申办/合作机构-

NCT01336660 / Completed临床2/3期

Phase 2/3 Study for Scorpion North Africa Middle East Envenomation With a Immune F(ab')2 (Equine) Antivenom Alacramyn NAMO. A Randomized, Double-Blind, Placebo-controlled, Prospective and Multicenter Study

This study has the objective to demonstrate the effectiveness of Alacramyn NAMO in the treatment of North Africa and Middle East scorpions envenomation by reducing the severity of envenomation. The primary endpoint is make a comparison between antivenom and placebo groups, at 4 hours after study drug, of the number of cases showing improvement in class of envenomation.

开始日期2018-07-21

申办/合作机构

Instituto Bioclon SA de CV

[+1]

100 项与 Equine F(ab')2 antivenom(Instituto Bioclon) 相关的临床结果

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100 项与 Equine F(ab')2 antivenom(Instituto Bioclon) 相关的转化医学

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100 项与 Equine F(ab')2 antivenom(Instituto Bioclon) 相关的专利（医药）

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6

项与 Equine F(ab')2 antivenom(Instituto Bioclon) 相关的文献（医药）

2020-11-01·Complementary Therapies in Medicine4区 · 医学

Cryotherapy as a coadjuvant in crotaline snakebite management with F(ab’)2 antivenom: A randomized pilot study

4区 · 医学

Article

作者: Moreno-Eutimio, Mario Adán ; Pastelin-Palacios, Rodolfo ; Canul-Caamal, Miguel Antonio ; Escalante-Galindo, Patricia ; Madrigal-Anaya, Jesús Del Carmen

INTRODUCTIONLocal cryotherapy induces vasoconstriction, which leads to a reduction in the inflammatory process. However, the effectiveness of local cryotherapy as a coadjuvant in the treatment of snakebite with F(ab')₂ antivenom is unknown.OBJECTIVETo describe the clinical effectiveness of local cryotherapy as a coadjuvant in patients with snakebite treated with F(ab')₂ antivenom therapy at the Hospital Juárez de Mexico.MATERIAL AND METHODSPatients with grade II snakebite envenomation according to the Christopher-Rodning classification system were enrolled from the Clinical Toxicology Service of the Hospital Juárez de México. One group of patients received F(ab')₂ antivenom therapy (Antivipmyn®) plus local cryotherapy, and the other group received only F(ab')₂ antivenom therapy.RESULTSThirty-eight patients were included, of whom 86.8 % were male (n = 33). Approximately 81.5 % of the subjects were injured in an upper extremity, while 18.5 % were injured in a lower extremities; 47.3 % of the subjects reported treatment of the snakebite prior to hospitalization (suction, the application of a tourniquet, incision of the bite site, or the application of traditional medicine). No differences were found concerning edema, swelling, and pain between the groups. The group that received local cryotherapy as a coadjuvant to F(ab')₂ antivenom therapy had a shorter hospital stay (Cohen's d = 1.33; 95 % confidence interval [95 % CI] = 0.74-1.62; p < 0.01) and received fewer doses of F(ab')₂ antivenom therapy (Cohen's d = 0.69; 95 % CI = 0.19-3.80; p = 0.03).CONCLUSIONSThe use of adequate local cryotherapy as a coadjuvant to F(ab')₂ antivenom therapy reduces the length of hospital stay and the number of doses of F(ab')₂ antivenom therapy used.

2019-09-01·Annals of Emergency Medicine1区 · 医学

The Efficacy of Antivenin Latrodectus (Black Widow) Equine Immune F(abʹ)2 Versus Placebo in the Treatment of Latrodectism: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial

1区 · 医学

Article

作者: Stephen Borron ; Victoria E. Anderson ; Kennon Heard ; Mark E Sutter ; Jude McNally ; Thomas C. Arnold ; Christopher P. Holstege ; Richard C. Dart ; Steven A. Seifert ; Dan Quan ; David A. Meurer ; Walter Garcia-Ubbelohde ; Sean P. Bush ; Danielle Campagne ; Randy I. Burnham ; Jean C.Y. Lo

STUDY OBJECTIVEThe antivenom currently available for treatment of systemic black widow envenomation (latrodectism) is composed of equine whole immunoglobin. Although considered effective, it has been associated with anaphylaxis and 2 reported fatalities. We test the efficacy and safety of new equine antivenom composed of purified F(ab')₂ antibody fragments.METHODSA randomized, double-blind, placebo-controlled trial was conducted at 16 sites across the United States. Subjects aged 10 years or older with moderate to severe pain because of black widow spider envenomation received F(ab')₂ antivenom or placebo. The primary outcome measure was treatment failure, which was defined as failure to achieve and maintain clinically significant reduction in pain for 48 hours posttreatment. Secondary measures of pain intensity differences and summed pain intensity difference were computed. Adverse events were recorded.RESULTSSixty patients were treated (29 antivenom and 31 placebo). The mean age was 39 years and 68% were male. There were 15 treatment failures in the antivenom group and 24 in the placebo group (P=.019). Differences in pain intensity difference between groups were lower at each postbaseline point, and the mean summed pain intensity difference was greater for the antivenom group (difference 2,133; 95% confidence interval 177 to 4,090). No deaths or serious drug-related adverse events were detected.CONCLUSIONThe F(ab')₂ antivenom met the predefined primary outcome of reduced treatment failures. Secondary outcomes of pain intensity difference and summed pain intensity difference also supported efficacy. The rate of symptom improvement in the placebo group was higher than expected, which may be related to enrollment criteria or placebo effect.

2013-04-01·Annals of Emergency Medicine1区 · 医学

A Randomized, Double-Blind, Placebo-Controlled Trial of a Highly Purified Equine F(ab)2 Antibody Black Widow Spider Antivenom

1区 · 医学

Article

作者: Richard C. Dart ; Tom Arnold ; Christopher Holstege ; Kennon Heard ; Sean Bush ; Elizabeth A. Spradley ; Walter Garcia-Ubbelohde ; Richard C. Clark ; Becki Bucher Bartelson ; Gregory W. Hendey ; Gregory Bogdan

STUDY OBJECTIVEBlack widow spider antivenom has never been tested in a randomized clinical trial, to our knowledge. We explore various efficacy measures for a novel F(ab)2 antivenom in patients with moderate to severe pain caused by black widow spider envenomation.METHODSA randomized, placebo-controlled, double-blind, clinical trial was conducted in 12 academic emergency departments. We included patients at least 10 years old with moderate to severe latrodectism. Subjects received either a single intravenous infusion of antivenom or placebo. Pain was assessed with the visual analog scale. The primary efficacy outcome was the difference in pre- and posttreatment visual analog scale score. Prospectively defined secondary outcomes included treatment failures and time to clinically important decrease in pain.RESULTSTwenty-four subjects were enrolled between October 2005 and October 2006; 13 were randomized to antivenom and 11 to placebo. The median change in visual analog scale at 150 minutes posttreatment was -50.0 mm (Interquartile Range [IQR] -67, -41 mm) in the antivenom treatment group and -46.0 mm (IQR -51, 0 mm) in the placebo treatment group (P=.14). There were 7 treatment failures (64%; 95% confidence interval 35% to 92%) in the placebo group and 3 (23%; 95% confidence interval 0.2% to 46%) in the antivenom group (P=.06). The median time to a clinically important decrease in pain after treatment was shorter in the antivenom group compared with the placebo group (30 minutes [IQR 30, 60 minutes] versus 90 minutes [IQR 30, 90 minutes]; P=.03). No serious adverse events or deaths were reported.CONCLUSIONAlthough the overall reduction in pain was similar for antivenom- and placebo-treated subjects, antivenom reduced pain more rapidly than placebo. No significant adverse events occurred in either group.

100 项与 Equine F(ab')2 antivenom(Instituto Bioclon) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
腹痛	临床3期	摩洛哥	Instituto Bioclon SA de CV	2018-07-21
腹泻	临床3期	摩洛哥	Instituto Bioclon SA de CV	2018-07-21
水肿	临床3期	摩洛哥	Instituto Bioclon SA de CV	2018-07-21
感觉减退	临床3期	摩洛哥	Instituto Bioclon SA de CV	2018-07-21
缺氧	临床3期	摩洛哥	Instituto Bioclon SA de CV	2018-07-21
恶心	临床3期	摩洛哥	Instituto Bioclon SA de CV	2018-07-21
呼吸功能不全	临床3期	摩洛哥	Instituto Bioclon SA de CV	2018-07-21
蝎子叮咬	临床3期	摩洛哥	Instituto Bioclon SA de CV	2018-07-21
心源性休克	临床3期	摩洛哥	Instituto Bioclon SA de CV	2018-07-21
呕吐	临床3期	摩洛哥	Instituto Bioclon SA de CV	2018-07-21