Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous Extracorporeal Membrane Oxygenation (ECMO) With a Heparin Bonded Circuit.

Heparin is a blood thinner used to prevent blood clots in patients on a form of life-support called ECMO. Heparin can cause bleeding - the most common complication of ECMO. New materials used in ECMO machines may help prevent clots - this could allow the use of lower doses of heparin which might reduce the risk of bleeding. Our study will compare low dose to high dose heparin in patients on ECMO. We think low dose heparin may be adequate to prevent clotting, but may cause less bleeding and be safer for patients.

开始日期2016-12-01

申办/合作机构

University of Arizona

NCT02901418

/ Unknown statusN/AIIT

According to the Venous Blood HBsAg State of Neonatus at Birth, Discussing the Efficiency of Personalized Blocking Method of HBV Maternal-neonatal Transmission in High-risk Newborns

Chronic hepatitis B (CHB) is a serious liver disease worldwide，HBV MTCT is the important reason to keep high prevalence of chronic HBV infection in China. Intrapartum infection is the main period of neonatal HBV infection. Injecting HBIG and hepatitis b vaccine immediately after birth is the most important method of blocking mother-to-child transmission of HBV. However, regular doses of HBIG combined with hepatitis b vaccine blocking measures still have a failure rate as high as 5%
15%.There are numerous studies to explore pregnancy women with HBV positive, especially high viral load of those women during pregnancy being treated with nucleoside analogs to increase the blocking rate of HBV MTCT, but there is still a failure rate of 2.2% to 18%. In this study, we will explore the efficiency of personalized blocking method of HBV maternal-neonatal transmission in high-risk newborns,according to the venous blood HBsAg state of neonatus at birth.

开始日期2015-07-01

申办/合作机构

北京地坛医院

NCT02417207

/ Unknown status临床4期IIT

Entecavir Combined Short-term Intravenous Hepatitis B Immune Globulin (HBIG) to Prevent Hepatitis B Recurrence After Liver Transplantation

The purpose of this study is to observe a new scheme can achieve is the same as the traditional scheme of the effect of preventing hepatitis B recurrence.

开始日期2015-04-01

申办/合作机构

中山大学附属第三医院

100 项与 Hepatitis B Immune Globulin(Grifols) 相关的临床结果

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100 项与 Hepatitis B Immune Globulin(Grifols) 相关的转化医学

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100 项与 Hepatitis B Immune Globulin(Grifols) 相关的专利（医药）

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1,084

项与 Hepatitis B Immune Globulin(Grifols) 相关的文献（医药）

2025-03-01·JHEP Reports

Liver transplantation for HBV-related liver disease: Impact of prophylaxis for HBV on HCC recurrence

Article

作者: Di Benedetto, Clara ; De Simone, Paolo ; Bhoori, Sherrie ; Mazzaferro, Vincenzo ; De Carlis, Luciano ; Frassanito, Gabriella ; Magro, Bianca ; Lanza, Alfonso Galeota ; Passigato, Nicola ; Trapani, Silvia ; Pagano, Duilio ; Russo, Francesco Paolo ; Lionetti, Raffaella ; Fagiuoli, Stefano ; Donato, Maria Francesca ; De Maria, Nicola ; Martini, Silvia ; Morelli, Maria Cristina ; Giannini, Edoardo ; Battistella, Sara ; Pasulo, Luisa ; Biolato, Marco ; Svegliati Baroni, Gianluca ; Turco, Laura ; Lenci, Ilaria ; Piano, Salvatore ; Ferri, Flaminia ; Fornasiere, Ezio ; Manuli, Chiara ; Angeli, Paolo ; Vacca, Pier Giuseppe ; Grossi, Paolo ; Rendina, Maria ; Giannelli, Valerio ; Marenco, Simona ; Toniutto, Pierluigi ; Forastiere, Domenico ; Scandali, Giulia ; Ghinolfi, Davide ; Zanetto, Alberto ; Ponziani, Francesca Romana ; Lauterio, Andrea ; Burra, Patrizia ; Mameli, Laura ; Ferrarese, Alberto ; Angrisani, Debora ; Aghemo, Alessio

Background & AimsConflicting data exist regarding optimal prophylaxis for HBV recurrence (HBV-R) after liver transplantation (LT), particularly in patients with hepatocellular carcinoma (HCC). We assessed current practices for HBV-R prophylaxis in Italy, evaluating rates, risk factors, and the clinical impact of HBV-R and HCC-R.MethodsWe performed a multicentric, retrospective study involving 20 Italian LT centers. All patients who underwent LT for HBV-related liver diseases between 2010 and 2021 were included. Logistic regression was used to identify predictors of HBV-R and HCC-R. Survival curves were estimated with the Kaplan-Meier method and compared with the log-rank test.ResultsWe included 1,205 LT recipients (60.8% with HCC). HBV prophylaxis was prescribed in 99.7% of recipients, mostly with lifelong hepatitis B immunoglobulin+nucleos(t)ide analogues (HBIG+NUCs) (83.9%). Rates of HBV-R were 2.1% and 3.1% in patients transplanted without and with HCC, respectively. Median times from LT were 60 [9.5-77.5] and 5.5 [1-13] months, respectively. Recipients on lifelong HBIG+NUCs experienced lower rates of HBV-R than those in whom HBIG was withdrawn, used only during LT, or in those who received NUCs alone (2.3% vs. 6.2% vs. 1.9% vs. 8%, respectively; p = 0.042). In recipients with HCC, HCC-R rate was 10.8% (median time from LT: 18 months). At multivariate analysis, HBV-R (odds ratio [OR] 10.329; 95% CI 3.665-29.110), Child-Pugh C (OR 3.519; 95% CI 1.305-9.484), and microvascular invasion (OR 3.088; 95% CI 1.692-5.634) were independently associated with HCC-R. Five-year survival was lower in recipients who experienced HCC-R (32.5% vs. 92.4% in those who did not; p <0.001).ConclusionIn Italy, HBV prophylaxis is mostly based on lifelong HBIG+NUCs. HBV-R was rare and not associated with survival in patients transplanted for decompensated cirrhosis. In patients transplanted for HCC, HBV-R was independently associated with HCC-R. The clinical implications of these findings deserve further investigation.Impact and implicationsIn Italy, the combination of high-barrier nucleos(t)ide analogues and hepatitis B immunoglobulins remains the most widely used regimen for antiviral prophylaxis following liver transplantation for HBV-related liver disease. Hepatitis B recurrence after liver transplantation is a rare event and not associated with reduced survival. In transplant recipients with hepatocellular carcinoma, HBV recurrence was independently associated with hepatocellular carcinoma recurrence, though this may simply reflect an epiphenomenon without any causal relationship.

2025-02-04·JAMA

A Randomized Clinical Trial

Article

作者: Zhang, Hua ; Dai, Erhei ; Pan, Calvin Q. ; Zou, Huaibin ; Zheng, Thomas Q. ; Chen, Xiuli ; Yang, Cuili ; Zhu, Lin ; Wu, Jinjuan ; Wang, Yuming ; Li, Suwen ; Mei, Shanshan ; Chen, Tianyan ; Liu, Yingxia ; Mo, Zhongfu

ImportanceStandard care for preventing mother-to-child transmission (MTCT) of hepatitis B virus (HBV) in highly viremic mothers consists of maternal antiviral prophylaxis beginning at gestational week 28 combined with an HBV vaccine series and HBV immune globulin (HBIG) at birth. However, HBIG is unavailable in some resource-limited areas.ObjectiveTo determine whether initiating tenofovir disoproxil fumarate (TDF) at gestational week 16 combined with HBV vaccinations for infants is noninferior to the standard care of TDF at gestational week 28 combined with HBV vaccinations and HBIG for infants in preventing MTCT in mothers with HBV and high levels of viremia.Design, Setting, and ParticipantsAn unblinded, 2-group, randomized, noninferiority clinical trial was conducted in 7 tertiary care hospitals in China. A total of 280 pregnant individuals (who all identified as women) with HBV DNA levels greater than 200 000 IU/mL were enrolled between June 4, 2018, and February 8, 2021. The final follow-up occurred on March 1, 2022.InterventionsPregnant individuals were randomly assigned to receive either TDF starting at gestational week 16 with HBV vaccinations for the infant or TDF starting at gestational week 28 with HBV vaccinations and HBIG administered to the infant.Main Outcomes and MeasuresThe primary outcome was the MTCT rate, defined as detectable HBV DNA greater than 20 IU/mL or hepatitis B surface antigen positivity in infants at age 28 weeks. Noninferiority was established if the MTCT rate in the experimental group did not increase by more than an absolute difference of 3% compared with the standard care group, as measured by the upper limit of the 2-sided 90% CI.ResultsAmong 280 pregnant individuals who enrolled in the trial (mean age, 28 years; mean gestational age at enrollment, 16 weeks), 265 (95%) completed the study. Among all live-born infants, using the last observation carried forward, the MTCT rate was 0.76% (1/131) in the experimental group and 0% (0/142) in the standard care group. In the per-protocol analysis, the MTCT rate was 0% (0/124) in the experimental group and 0% (0/141) in the standard care group. The between-group difference was 0.76% (upper limit of the 2-sided 90% CI, 1.74%) in all live-born infants and 0% (upper limit of the 2-sided 90% CI, 1.43%) in the per-protocol analysis. Both comparisons met the criterion for noninferiority. Rates of congenital defects and malformations were 2.3% (3/131) in the experimental group and 6.3% (9/142) in the standard care group (difference, 4% [2-sided 95% CI, −8.8% to 0.7%]).Conclusions and RelevanceAmong pregnant women with HBV and high levels of viremia, TDF beginning at gestational week 16 combined with HBV vaccination for infants was noninferior to the standard care of TDF beginning at gestational week 28 combined with HBIG and HBV vaccination for infants. These results support beginning TDF at gestational week 16 combined with infant HBV vaccine to prevent MTCT of HBV in geographic areas where HBIG is not available.Trial RegistrationClinicalTrials.gov Identifier: NCT03476083

2025-01-01·Hepatology Research

Novel protocol for prevention from hepatitis B reactivation following living‐donor liver transplantation

Article

作者: Iseda, Norifumi ; Tsutsui, Yuriko ; Yoshizumi, Tomoharu ; Itoh, Shinji ; Toshida, Katsuya ; Ishikawa, Takuma ; Yoshiya, Shohei ; Toshima, Takeo ; Bekki, Yuki ; Nakayama, Yuki ; Izumi, Takuma

AbstractAimReactivation of hepatitis B virus (HBV) after liver transplantation (LT) remains a problem; thus, development of more effective HBV reactivation prophylaxis is desirable. We evaluated the efficacy of a combination of a long‐term nucleotide analog (NA), such as entecavir (ETV) or tenofovir alafenamide (TAF), and short‐term hepatitis B immunoglobulin (HBIG) in preventing HBV reactivation and compared it with conventional HBV prophylaxis.MethodsBetween February 1999 and August 2023, 135 patients underwent living‐donor liver transplantation for liver cirrhosis or acute liver failure caused by HBV infection or received an LT from a hepatitis B core antibody‐positive donor. Recipients who had undergone LT were classified as being in the first or second era (namely until September 2017 and from October 2017), respectively, and outcomes of prophylaxis against HBV reactivation were compared between the two eras.ResultsIn the second era, recipients with HBV‐related disease or who had received hepatitis B core antibody‐positive liver received combination therapy with short‐term HBIG and an NA such as TAF and ETV long‐term. The duration of HBIG treatment was markedly shorter than in the first era in both categories of patients and HBIG could be discontinued in all cases. Surprisingly, we observed HBV reactivation in the first era, but not in the second era, in both groups.ConclusionsWe have established a protocol for prophylaxis against HBV reactivation using a combination of short‐term HBIG and long‐term NA. This protocol was found to be sufficient to prevent HBV reactivation after LT.

项与 Hepatitis B Immune Globulin(Grifols) 相关的新闻（医药）

2024-11-20

·医脉通

郑树森院士：权威指引，照亮前路——《中国肝移植受者抗胸腺细胞免疫球蛋白临床应用指南》正式定稿！

前言近年来，免疫抑制剂抗胸腺细胞球蛋白（ATG）已被应用于肝移植的免疫抑制诱导治疗与排斥反应时免疫抑制治疗，以提高移植器官和受者的存活率。然而，ATG在肝移植领域的临床应用尚未形成统一标准，亟需通过权威引领规范其使用。 2024年11月17日，《中国肝移植受者抗胸腺细胞免疫球蛋白临床应用指南》定稿会，暨“植引非凡”启动仪式在杭州举办，将为规范ATG在肝移植领域中的临床应用提供重要指引。在此，医脉通特邀浙江大学医学院附属第一医院郑树森院士接受采访，分享指南制定背后的故事以及对“植引非凡”项目的期望，以期为临床实践带来启发，助力广大移植患者长期生存。医脉通：肝移植被誉为外科皇冠上最璀璨的明珠，是治疗终末期肝病及肝脏肿瘤最有效的手段之一，其术后的中长期管理和免疫治疗方案的制定是影响患者长期存活和生存质量的关键要素。作为《指南》的牵头专家，请您谈谈制定此《指南》的背景与初衷是什么？郑树森院士肝移植是各种终末期肝病唯一有效的治疗手段1。截至目前，我国实施肝移植手术例数累计近4万例2，其中尸体肝移植和活体肝移植受者术后5年的累积生存率分别达68.9%和88.2%3，彰显了我国医疗团队在肝移植技术上的实力。移植排斥反应是影响肝移植术后移植肝和患者长期存活的关键因素，而免疫抑制治疗是预防和治疗移植排斥反应发生的主要策略4，研究显示，使用免疫抑制剂方案的肝移植受者术后5年总体存活率可达80%左右5。近年来，随着我国肝移植手术量逐渐增多，免疫抑制治疗在肝移植领域中的应用亦呈现出日益增长的趋势。 ATG已被应用于肝移植的免疫抑制诱导治疗与排斥反应时免疫抑制治疗，但当前在ATG的临床应用中尚缺乏统一的标准。为了进一步推动我国肝移植领域向更加标准化、规范化方向发展，结合国内外文献以及临床实践，经过临床专家讨论制定了该《指南》，旨在为肝移植受者中ATG的临床应用提供指导建议。医脉通：请您结合本次指南的内容，谈谈不久后《指南》的发布对于ATG用于临床肝移植有怎样的指导意义？郑树森院士目前，肝移植术后免疫抑制治疗尚无统一标准，各移植中心都有自己的经验与方案。免疫抑制剂种类繁多，肝移植医师应全面掌握各类免疫抑制剂的药理特点及不良反应，正确、有效地评估受者免疫状态并结合其自身状况，根据免疫抑制剂应用原则有针对性地制订免疫抑制方案6。《指南》基于英国牛津大学循证医学中心制定的证据分级和推荐强度标准制定，各项推荐意见证据充分，可信度高。临床应用指导全面细致，从不同病情处理到用药的各个环节均有涉及。始终贯穿个体化原则，兼顾治疗效果与减少副作用。众多权威专家参与，保证了内容的专业性与全面性。同时，为后续研究指明方向，助力学科持续进步。基于上述特点，《指南》能够为临床医生在肝移植中使用ATG提供科学、规范的指导，更好地助力临床医生合理用药。医脉通：本指南凝聚了中国医师协会器官移植分会，中华医学会器官移植分会众多专家的心血。您认为此《指南》发布后将对临床医生和患者产生哪些积极的影响？您对指南的发布有哪些期待？郑树森院士《指南》的发布意义重大，为ATG在临床肝移植应用提供了统一标准和规范指导。有助于医生科学决策，优化免疫抑制方案，提高肝移植受者长期生存率和生活质量，推动肝移植领域不断发展。《指南》的发布对临床医生和患者都有积极影响。对医生而言：①《指南》清晰阐述了ATG在预防和治疗急性排斥反应中的作用、适用情况和剂量方案，有助于医生准确用药；②《指南》为不同病情的肝移植受者提供了针对性策略，有助于精准医疗；③《指南》基于多项研究成果和专家经验制定，可增强医生选择ATG治疗方案的信心；对患者而言，医生依据指南合理应用ATG，能有效预防和治疗急性排斥反应，保障治疗安全，提高移植肝存活率，延长患者的生存期。希望通过多种方式广泛传播《指南》，推动基于患者个体差异的临床研究，为精准个性化治疗提供依据。同时，期待国内医生在国际交流中分享经验，吸收先进理念技术，定期更新指南，提升我国在该领域的国际影响力，共同推动全球器官移植事业发展。医脉通：在本次《指南》定稿会上，“植引非凡”项目正式启动，您希望该项目能起到什么作用，谈谈您对该项目的期望。郑树森院士 “植引非凡”项目在我国器官移植事业的发展中具有重要意义。期望在技术方面，能够大力引入和推广国际前沿技术，同时激发国内创新活力，在器官排斥应对、长期存活提升等关键领域实现重大突破，让我国器官移植技术水平迈向新高度。在规范与质量把控方面，期望制定并广泛普及统一的操作规范，建立健全质量控制体系，确保手术安全与患者良好预后，提升整个行业的质量水准。在国际合作领域，期望搭建起坚实的学术交流平台，积极推动与国际一流医疗机构的深度合作，拓宽国内专业人员的视野，让我国器官移植事业更好地融入全球发展潮流。相信“植引非凡”项目一定能不负众望，为我国器官移植事业开创更加辉煌的未来。专家简介郑树森院士浙江大学医学院附属第一医院中国工程院院士中国医学科学院学部委员法国国家医学科学院外籍院士国家卫生健康委多器官联合移植研究重点实验室主任国家肝脏移植质控中心主任中华医学会副会长中国胰腺病学会副会长中国医师协会器官移植医师分会会长中国肝移植注册中心科学委员会主席浙江大学学术委员会副主任浙江大学器官移植研究所所长浙江大学医学院附属第一医院肝胆胰外科、器官移植学科带头人 Hepatobiliary Pancreatic Diseases International 主编主要学术贡献： 1993年浙江省第一例肝移植，推动国内第二次浪潮建立肝癌肝移植受者选择标准——杭州标准创建小剂量HBIG联合核苷类似物预防新方案创建成人右半肝活体肝移植技术创新体系承担973首席2项，重大专项2项，创新群体3项以通讯作者发表TOP期刊SCI论文700余篇主编专著10本，杂志2本（SCI收录1本）获国家科技进步特等奖1项，一等奖1项，二等奖2项获国家科技进步奖创新团队奖1项何梁何利科学与技术进步奖获得者参考文献： 1.刘贵容,等.中华物理医学与康复杂志,2022,44(2):189-192. 2.中国器官移植发展基金会. 中国器官移植发展报告(2021) [M]. 北京: 人民卫生出版社 3.窦科峰,等. 中华外科杂志,2024,62(1):1-5. 4.闫鑫,史等. 药学进展,2018,42(10):754-762. 5.姜亦洲, 等.中华器官移植杂志,2020,41 (03): 189-192. 6.石炳毅,等.中国器官移植临床诊疗技术规范:2020版[M].人民卫生出版社,2021. MAT-CN-2419238.V1.0.2024.11 -THE END- 医脉通是专业的在线医生平台，“感知世界医学脉搏，助力中国临床决策”是平台的使命。医脉通旗下拥有「临床指南」「用药参考」「医学文献王」「医知源」「e研通」「e脉播」等系列产品，全面满足医学工作者临床决策、获取新知及提升科研效率等方面的需求。

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100 项与 Hepatitis B Immune Globulin(Grifols) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J06BB04	DB05276

研发状态

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适应症	国家/地区	公司	日期
乙型肝炎	西班牙	Grifols SA	2012-01-01

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适应症	最高研发状态	国家/地区	公司	日期
乙型肝炎	临床前	意大利	Instituto Grifols SA	2010-07-01
慢性乙型肝炎	临床前	西班牙	Instituto Grifols SA	2003-10-01

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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


EASL2020	N/A	乙型肝炎 HBsAg-positive \| anti-HBc positive	1,355	HBIG monotherapy	壓積壓願夢鹽壓艱鬱艱(顧製獵衊鹹齋範簾願範) = 鏇憲構憲憲壓積餘構夢選繭鹽繭艱願鬱鬱獵夢 (糧糧鏇蓋鏇夢鬱獵衊憲 ) 更多	积极	2020-08-27
				Combination treatments with antiviral prophylaxis and HBIG	壓積壓願夢鹽壓艱鬱艱(顧製獵衊鹹齋範簾願範) = 簾窪襯簾夢觸艱蓋壓艱選繭鹽繭艱願鬱鬱獵夢 (糧糧鏇蓋鏇夢鬱獵衊憲 ) 更多
EASL2019	N/A	乙型肝炎 HBeAg status \| maternal HBV DNA load	16,121	100 IU HBIG	窪積醖網淵築獵艱襯壓(鬱構觸鏇網蓋淵鹽廠簾) = 網網廠積淵願醖壓膚網衊鹹淵廠淵淵鏇醖醖願 (衊製願簾廠製鏇鑰窪願, 4% − 9%)	-	2019-04-13
				200 IU HBIG	窪積醖網淵築獵艱襯壓(鬱構觸鏇網蓋淵鹽廠簾) = 鏇範顧願鬱糧鬱觸積齋衊鹹淵廠淵淵鏇醖醖願 (衊製願簾廠製鏇鑰窪願, 5% − 8%)
EASL2019	N/A	乙型肝炎	18	HBIG and NA therapy	構壓鬱範築繭遞獵觸鏇(膚衊醖夢窪糧顧廠廠鏇) = 構膚衊獵糧壓簾築觸醖獵窪醖蓋淵構鹹簾繭製 (構衊窪淵艱觸廠簾範夢 ) 更多	-	2019-04-12
				NA therapy only	構壓鬱範築繭遞獵觸鏇(膚衊醖夢窪糧顧廠廠鏇) = 範簾獵遞構鬱範築築範獵窪醖蓋淵構鹹簾繭製 (構衊窪淵艱觸廠簾範夢 ) 更多
NCT01131065 (CTgov)	临床3期	乙型肝炎	15	Hepatitis B immune globulin	遞製積獵範壓壓鑰醖膚(鏇醖窪獵鬱膚淵蓋構觸) = 夢衊顧鑰繭積壓醖膚壓觸夢選蓋襯憲淵壓夢蓋 (餘範願齋窪衊鬱廠膚餘, 艱襯築築獵壓廠鑰鏇壓 ~ 獵夢鹹願鏇鏇繭觸醖襯) 更多	-	2016-02-01