Immune Globulin Intravenous (Human) (Bio Products)(Immune Globulin Intravenous (Human) (Bio Products)) - 在研适应症：原发性免疫缺陷疾病，免疫性血小板减少症_专利_临床

概要

基本信息

药物类型

免疫球蛋白

别名

Immune globulin(Bio Products Laboratory)、Subgam、Subgam-VF

+ [1]

靶点-

作用方式

调节剂

作用机制

免疫调节剂

治疗领域

免疫系统疾病遗传病与畸形血液及淋巴系统疾病+ [1]

在研适应症

原发性免疫缺陷疾病免疫性血小板减少症

非在研适应症

Bruton型无丙种球蛋白血症慢性特发性血小板减少性紫癜普通可变性免疫缺陷+ [4]

原研机构

Bio Products Laboratory USA, Inc.

在研机构

Bio Products Laboratory USA, Inc.

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2009-09-17),

原发性免疫缺陷疾病免疫性血小板减少症

最高研发阶段(中国)-

特殊审评-

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关联

8

项与 Immune Globulin Intravenous (Human) (Bio Products) 相关的临床试验

NCT01884311

/ Completed临床3期

A Phase III, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subgam-VF in Primary Immunodeficiency Diseases

The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin (IGIV) therapy.

开始日期2015-08-20

申办/合作机构

Bio Products Laboratory USA, Inc.

NCT01963143

/ Completed临床3期

A Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases

The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a 28-day dosing interval (AUC0-28) in a cohort of adult subjects.
The secondary objectives are to demonstrate the bioequivalence of Gammaplex® 10 IGIV and Gammaplex® 5% IGIV with respect to area under the curve within a 21-day dosing interval (AUC0-21) in adult subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV and Gammaplex 5% IGIV including Immunoglobulin G (IgG) trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV and Gammaplex 5% IGIV in adults subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV including IgG trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV in pediatric subjects.

开始日期2014-02-01

申办/合作机构

Bio Products Laboratory USA, Inc.

NCT02199925

/ Unknown status临床4期

A Phase IV, Single-site, Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum

If autism is the consequence of a chronic inflammatory process preventing the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism. IGIV treatment has been known to suppress inflammation and has been used in the treatment of inflammatory conditions and autoimmune diseases.

开始日期2013-06-01

申办/合作机构

IMMUNOe Health Centers

[+1]

100 项与 Immune Globulin Intravenous (Human) (Bio Products) 相关的临床结果

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100 项与 Immune Globulin Intravenous (Human) (Bio Products) 相关的转化医学

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100 项与 Immune Globulin Intravenous (Human) (Bio Products) 相关的专利（医药）

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11

项与 Immune Globulin Intravenous (Human) (Bio Products) 相关的文献（医药）

2019-11-01·Journal of infusion nursing : the official publication of the Infusion Nurses Society

A Study of Tolerability, Satisfaction, and Cost Reduction Using a 10% Immunoglobulin Product at Higher Administration Rates

Article

作者: Fadeyi, Michael ; Bauer, Susan ; Chan, Sheryl

Gammaplex 10% (immune globulin intravenous [human], Bio Products Laboratory, Ltd) can be administered with a 15-minute rate-escalation protocol. This analysis examined safety, patient satisfaction, and cost savings in 49 patients administered Gammaplex 10% via rapid infusion over 11 months. Fourteen patients reported 38 adverse reactions, 37 of which were deemed minor/moderate. Patient satisfaction was very good/outstanding. Infusions were estimated to be 2.4 hours shorter than previously administered intravenous immunoglobulin infusions, saving $151.61 per visit in nursing costs. Rapid infusion of Gammaplex 10% was found to be a safe option to reduce the costs of intravenous immunoglobulin treatment while maintaining patient satisfaction.

2017-10-01·Immunotherapy4区 · 医学

Gammaplex ^® 5 and 10% in the Treatment of Primary Immunodeficiency and Chronic Immune Thrombocytopenic Purpura

4区 · 医学

Review

作者: Wasserman, Richard L

Immunoglobulin G is used to both prevent infection in primary immunodeficiency diseases (PIDs) and prevent bleeding in immune thrombocytopenic purpura. Gammaplex is a highly purified human intravenous immunoglobulin G available as 5 and 10% liquid formulations. Gammaplex 5% has proven efficacy and safety in PID and immune thrombocytopenic purpura, protecting against serious acute bacterial infections and treating bleeding by improving platelet counts, respectively. The therapeutic effect of Gammaplex 10% is expected to be similar to that of Gammaplex 5% based on demonstrated bioequivalence in a bridging study in PID. The availability of Gammaplex 10% provides another option to individualize therapy according to patient needs, allowing a 34% reduction in infusion time without compromising safety and tolerability.

2017-08-01·Journal of clinical immunology

Erratum to: Evaluation of the Safety, Tolerability, and Pharmacokinetics of Gammaplex® 10% Versus Gammaplex® 5% in Subjects with Primary Immunodeficiency

Article

作者: Norton, Miranda ; Moy, James N ; Melamed, Isaac R ; Stein, Mark R ; Jolles, Stephen ; Wasserman, Richard L

The article was originally published Online First without open access.After publication in volume 37, issue 3, page 301-310 the author decided to opt for Open Choice and to make the article an open access publication.

1

项与 Immune Globulin Intravenous (Human) (Bio Products) 相关的新闻（医药）

2023-03-30

·PRNewswire

CSI Pharmacy Announces Limited Distribution Agreement for Gammaplex

NASH, Texas, March 30, 2023 /PRNewswire/ -- CSI Pharmacy, LLC, an independent, national specialty pharmacy and home infusion provider, today announced an agreement with Bio Products Laboratory (BPL) for limited distribution rights to its immune globulin product Gammaplex®. Access to Gammaplex means CSI Pharmacy is now able to dispense all FDA-approved immune globulin products. The company expects to begin stocking Gammaplex immediately. "Gammaplex not only expands our product portfolio, but it increases treatment options for patients who have various conditions," said COO Randy Broyles, RPh. "By diversifying our portfolio with BPL and other plasma product manufacturers, we're strengthening our industry partnerships, as well as strengthening the supply chain for our patients and customers." Immune globulin products contain human antibodies, derived primarily from donated human plasma. Multiple immune globulin products are manufactured for the U.S. market. They are commonly used to treat conditions such as primary and secondary immunodeficiencies, autoimmune neurological and dermatological disorders, as well as hundreds of other conditions believed to be immune mediated. "We want to thank BPL for trusting CSI to deliver a positive patient experience with its products," remarked co-founder and CEO James Sheets, PharmD. "As our company continues to grow, we will need partnerships like this one to secure product availability for customers, now and into the future." A CSI PHARMACY CSI Pharmacy is a national specialty pharmacy dedicated to serving patients with chronic and rare illnesses. Founded by pharmacists in 2014, the company specializes in treating rare diseases with biologics and plasma-derived therapies. It employs specially trained infusion nurses to provide these treatments to patients around the country. CSI continues to be led by co-founder and CEO, James Sheets, PharmD. Today, CSI Pharmacy is licensed to dispense in 48 states, plus D.C., and is accredited by two of the nation's leading specialty pharmacy accrediting bodies: the Accreditation Commission for Health Care (ACHC) and URAC. SOURCE CSI Pharmacy, LLC

引进/卖出

100 项与 Immune Globulin Intravenous (Human) (Bio Products) 相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
原发性免疫缺陷疾病	美国	Bio Products Laboratory USA, Inc.	2009-09-17
免疫性血小板减少症	美国	Bio Products Laboratory USA, Inc.	2009-09-17

未上市

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
Bruton型无丙种球蛋白血症	临床3期	美国	Bio Products Laboratory USA, Inc.	2014-02-01
Bruton型无丙种球蛋白血症	临床3期	匈牙利	Bio Products Laboratory USA, Inc.	2014-02-01
Bruton型无丙种球蛋白血症	临床3期	英国	Bio Products Laboratory USA, Inc.	2014-02-01
慢性特发性血小板减少性紫癜	临床3期	美国	Bio Products Laboratory USA, Inc.	2007-09-01
慢性特发性血小板减少性紫癜	临床3期	阿根廷	Bio Products Laboratory USA, Inc.	2007-09-01
慢性特发性血小板减少性紫癜	临床3期	印度	Bio Products Laboratory USA, Inc.	2007-09-01
普通可变性免疫缺陷	临床3期	美国	Bio Products Laboratory USA, Inc.	2006-01-01
高IgM免疫缺陷综合征	临床3期	美国	Bio Products Laboratory USA, Inc.	2006-01-01
低丙种球蛋白血症	临床3期	美国	Bio Products Laboratory USA, Inc.	2006-01-01
性联遗传低丙种球蛋白血症	临床3期	美国	Bio Products Laboratory USA, Inc.	2006-01-01

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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


NCT01884311 (SCIG03, CTgov)	临床3期	普通可变性免疫缺陷 \| Bruton型无丙种球蛋白血症 \| 高IgM免疫缺陷综合征	38	Subgam	積壓窪鏇糧衊襯憲繭簾 = 餘憲鏇衊遞蓋衊夢齋積積衊襯網顧壓願襯夢醖 (鏇糧廠繭襯廠選廠觸製, 艱鹽獵鑰壓艱艱獵鹹蓋 ~ 蓋鹹餘鏇壓醖醖壓網遞) 更多	-	2018-09-12
NCT01289847 (CTgov)	临床4期	普通可变性免疫缺陷 \| Wiskott-Aldrich综合征 \| Bruton型无丙种球蛋白血症 ... 更多	25	Gammaplex	鹽獵齋壓鹹選築鏇餘淵 = 範觸蓋觸夢醖鏇衊積鏇觸積醖積淵鬱顧齋衊窪 (齋鬱鏇鏇餘糧糧製淵憲, 觸醖鑰遞窪艱構壓廠網 ~ 膚鏇窪蓋鹽網遞願積廠) 更多	-	2014-12-23
NCT00504075 (CTgov)	临床3期	慢性特发性血小板减少性紫癜	35	GAMMAPLEX	簾夢簾夢繭艱蓋製鬱糧 = 簾願夢鹽夢餘衊簾願顧壓遞範齋糧鹽構糧艱簾 (鹹齋淵積鹹壓觸憲衊鬱, 淵觸襯糧襯範鬱膚顧遞 ~ 觸衊衊簾醖窪鹹糧餘襯) 更多	-	2012-06-06
NCT00278954 (CTgov)	临床3期	普通可变性免疫缺陷 \| 低丙种球蛋白血症 \| Wiskott-Aldrich综合征 ... 更多	50	Gammaplex+Intravenous immunoglobulin	範醖齋築憲衊齋構淵選 = 積壓壓遞鏇製選壓憲衊蓋範鏇遞製齋簾壓齋淵 (窪網艱觸築願鏇製簾觸, 製鹽夢艱築鏇淵簾鏇鹹 ~ 齋繭積襯鬱夢襯鏇醖鏇) 更多	-	2010-01-28