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+ [3]

原研机构

Bio Products Laboratory USA, Inc.

在研机构

Bio Products Laboratory USA, Inc.

非在研机构-

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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9

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.

2017-08-01·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.

2017-04-01·Journal of clinical immunology

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

Abstract:

Purpose:

This phase 3, multicenter, open-label, randomized, two-period, crossover bioequivalence trial evaluated the safety, tolerability, and pharmacokinetics of intravenous immunoglobulins (IVIGs) Gammaplex 5% and Gammaplex 10% in 33 adults and 15 children with primary immunodeficiency diseases (PIDs).

Methods:

Eligible adults received five Gammaplex 5% infusions followed by five Gammaplex 10% infusions, or vice versa, stratified by a 21- or 28-day dosing regimen. Pediatric subjects received five Gammaplex 10% infusions only.

Results:

The primary objective, to demonstrate the bioequivalence of Gammaplex 10% and Gammaplex 5% at the 28-day dosing interval, was met based on the Gammaplex 10%/Gammaplex 5% ratio of area under the concentration versus time curve (AUC0–28) values. Throughout the study, total immunoglobulin G trough levels were well maintained, with total values generally ≥600 mg/dL (minimum level for study inclusion). At the dosing schedules and infusion rates used in this study, safety and tolerability were comparable and acceptable in adult and pediatric PID subjects treated with Gammaplex 10% and 5%.

Conclusions:

In this study, the first direct comparison of 5% IVIG and 10% IVIG products in PID subjects, the pharmacokinetic analysis demonstrated bioequivalence of Gammaplex 10% and Gammaplex 5% at the 28-day dosing interval. The Gammaplex 10% formulation was safe and well tolerated in pediatric and adult PID subjects. Based on the results from this bridging study in PID subjects, Gammaplex 10% could be expected to have a therapeutic effect similar to the licensed Gammaplex 5%, which has demonstrated efficacy and tolerability in patients with PID and idiopathic thrombocytopenic purpura.

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

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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
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
Wiskott-Aldrich综合征	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

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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	壓糧襯製窪構壓憲淵願(觸簾顧膚繭願窪觸選積) = 簾鹹餘鹽選鹽鹽鹽顧餘願膚糧齋廠齋醖積網壓 (簾憲窪網簾遞壓窪選獵, 構構網獵範遞鑰衊選積 ~ 觸範願齋鏇遞積獵餘蓋) 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	鏇鏇窪餘醖鹽獵鹹憲廠(廠醖範範鹹築鏇夢製鏇) = 繭觸網鹹廠鏇製積壓鹽顧範廠鹽願齋繭窪願糧 (齋鹽鑰襯選網選艱鏇鹽, 窪願鬱鑰鹹網糧膚夢鏇 ~ 選鏇憲廠獵衊網鏇鹹窪) 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	築範積獵觸獵襯夢齋窪(鹹糧鏇簾願觸觸願遞構) = 鏇艱淵築淵網憲壓餘願襯憲範簾獵淵鬱壓鹹選 (繭餘衊蓋淵選餘淵廠選, 繭鹽製淵築鹽鹽觸選餘 ~ 顧觸鹹膚窪繭襯網築顧) 更多	-	2012-06-06
NCT00278954 (CTgov)	临床3期	普通可变性免疫缺陷 \| Wiskott-Aldrich综合征 \| 高IgM免疫缺陷综合征 ... 更多	50	Gammaplex (Intravenous immunoglobulin)	網蓋壓齋簾鑰夢壓築膚(鹹夢遞構鹽膚醖糧齋醖) = 艱鬱襯構醖鬱顧壓衊網齋憲選選繭獵鑰製製襯 (製遞鹽選願獵選衊鹽鏇, 獵夢蓋觸鬱鏇鏇積簾鹹 ~ 膚糧蓋壓鹹襯窪鏇襯鑰) 更多	-	2010-01-28