Delving into the Latest Updates on Grifols Biologicals, Inc. with Synapse

Hypothesis: Improvement in cognitive dysfunction with IV albumin in patients with cirrhosis with prior HE and MHE lasts for several weeks after albumin infusion has ended, and is due to persistent improvement in inflammatory markers, endothelial dysfunction, albumin function and gut microbial changes.
This will be a single-arm, single-blind sequential trial of IV 25% albumin and IV saline over 8 weeks with biological sampling and cognitive and health related quality of life (HRQOL) testing with each subject acting as their own control.

开始日期2023-11-02

申办/合作机构

Grifols Biologicals, Inc.

NCT05382650 / RecruitingN/AIIT

Multicenter Safety Evaluation of Human Rabies Immune Globulin 300 IU/mL in Children

This observational study will be conducted across the Houston Methodist system, including all hospital-based and freestanding emergency departments (ED), and up to 4 additional sites in the United States. The safety of human rabies immune globulin (HRIG) 300 IU/mL product (HyperRAB®) in pediatric patients has not been fully established. The purpose of this study is to evaluate the safety of HRIG 300 IU/mL when given to pediatric patients per standard of care for rabies postexposure prophylaxis (PEP) in the ED.

开始日期2023-02-22

申办/合作机构

The Methodist Hospital Research Institute

[+1]

NCT04450654 / Withdrawn临床2期IIT

Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment (The MIGHT Trial)

This is a phase 2, pilot, randomized, placebo-controlled trial of Gamunex-C IVIG as mono-therapy for HMGCoA reductase auto-antibody positive (HMGCR) necrotizing myopathy. The trial will test the feasibility and initial efficacy of Gamunex-C IVIG mono-therapy in HMGCR necrotizing myopathy.

开始日期2022-05-01

申办/合作机构

University of Washington

[+1]

100 项与 Grifols Biologicals, Inc. 相关的临床结果

登录后查看更多信息

0 项与 Grifols Biologicals, Inc. 相关的专利（医药）

登录后查看更多信息

4

项与 Grifols Biologicals, Inc. 相关的文献（医药）

2016-08-01·Journal of Clinical Immunology2区 · 医学

Flebogamma® 5 % DIF Intravenous Immunoglobulin for Replacement Therapy in Children with Primary Immunodeficiency Diseases

2区 · 医学

Article

作者: Smits, William ; Ballow, Mark ; Pinciaro, Paul J ; Moy, James ; Craig, Timothy ; Ochs, Hans D ; Sleasman, John ; Kleiner, Gary

PURPOSEThe previous studies with Flebogamma(®) 5 % DIF intravenous immunoglobulin (IVIG) contained insufficient numbers of pediatric subjects to fully warrant a pediatric indication by the FDA. The objective of this study was to evaluate the efficacy, safety, and pharmacokinetics of Flebogamma® 5 % DIF for replacement therapy in children (age 2-16) with primary immunodeficiency diseases (PIDD).METHODSIVIG was administered at eight clinical sites to 24 subjects with well-defined PIDD at a dose of 300-800 mg/kg every 21-28 days for 12 months. The pharmacokinetics endpoint in this study was the dose-adjusted increment of the serum IgG trough levels.RESULTSThe calculated serious bacterial infection rate was 0.05/subject/year. The incidence of adverse events considered potentially related to IVIG during or within 72 h after completing an infusion was within the FDA guidance threshold of <40 % at each time point. Dose-adjusted incremental IgG levels remained approximately equal to or slightly greater than pre-study IgG levels (between 800 and 1000 mg/dL throughout) when the subjects were treated with IVIG therapy other than Flebogamma(®) DIF 5 % indicating no evidence of a different pharmacokinetic profile in this pediatric population if compared to those profiles in previous Flebogamma studies in predominately adult populations.CONCLUSIONSFlebogamma(®) 5 % DIF is efficacious and safe, has adequate pharmacokinetic properties, is well-tolerated, and maintains the profile of Flebogamma(®) 5 % for the treatment of children with primary humoral immunodeficiency diseases.

2014-09-01·Biologicals4区 · 生物学

Virus removal capacity at varying ionic strength during nanofiltration of AlphaNine® SD

4区 · 生物学

Article

作者: Winkler, Clint J ; Jorba, Nuria ; Herring, Steven W ; Shitanishi, Kenneth T

Nanofiltration is incorporated into the manufacturing processes of many protein biopharmaceuticals to enhance safety by providing the capacity to retain pathogens while allowing protein drugs to pass through the filter. Retention is mainly a function of size; however, the shape of the pathogen may also influence retention. The ability of the Viresolve(®) Pro nanofilter to remove different sized viruses during the manufacture of a Coagulation Factor IX (Alphanine(®) SD) was studied at varying ionic strength, a process condition with the potential to affect virus shape and, hence, virus retention. Eight viruses were tested in a scale-down of the nanofiltration process. Five of the viruses (EMCV, Reo, BVDV, HIV, PRV) were nanofiltered at normal sodium processing conditions and three (PPV, HAV and WNV) were nanofiltered at higher and lower sodium. Representative Reduction Factors for all viruses were ≥4.50 logs and removal was consistent over a wide range of ionic strength.

2010-07-01·Haemophilia2区 · 医学

Grifols’ factor IX concentrates: new findings in biochemical characteristics and safety profiles

2区 · 医学

Review

作者: Herring, S

A review.A review on two ultrapurified plasma-derived factor IX (pdFIX) products manufacture by Grifols: AlphaNine SD and Factor IX Grifols.s.

100 项与 Grifols Biologicals, Inc. 相关的药物交易

登录后查看更多信息

100 项与 Grifols Biologicals, Inc. 相关的转化医学

登录后查看更多信息

组织架构

使用我们的机构树数据加速您的研究。

登录

或

查看完整样例数据

管线布局

2024年11月05日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

批准上市

2

4

其他

登录后查看更多信息

当前项目

药物(靶点)	适应症	全球最高研发状态

Factor IX complex(Grifols) ( F10 x factor IX x factor VII x thrombin )	血友病B 更多	批准上市
Antihemophilic factor/von Willebrand factor complex(Grifols SA) ( F10 )	冯·维勒布兰德病更多	批准上市
Immune Globulin (Human)(Grifols)	糖尿病性神经病变更多	终止
Alpha1-proteinase inhibitor(Grifols SA) ( A1AT )	HIV感染更多	终止
纤维蛋白粘合剂（Grifols） ( fibrin )	出血更多	无进展