HBIG(HBIG) - 在研适应症：乙型肝炎_专利_临床

概要

基本信息

药物类型

免疫球蛋白

别名

HBIG、HBIG (Grifols)、Hepabulin Antibody injection

+ [9]

靶点-

作用机制

免疫调节剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段批准上市

首次获批日期

西班牙 (2012-01-01),

乙型肝炎

最高研发阶段(中国)-

特殊审评-

登录后查看首次获批时间轴

关联

8

项与 HBIG 相关的临床试验

NCT02966080 / WithdrawnN/AIIT

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 HBIG 相关的临床结果

登录后查看更多信息

100 项与 HBIG 相关的转化医学

登录后查看更多信息

100 项与 HBIG 相关的专利（医药）

登录后查看更多信息

1,134

项与 HBIG 相关的文献（医药）

2024-09-01·Journal of Paediatrics and Child Health

Prevention of vertical transmission of hepatitis B: A retrospective review of a 5‐year maternal–infant cohort in London

Article

作者: O'Mahony, Elizabeth ; Raghunanan, Sophie ; Foster, Caroline ; Brown, Ashley

AimsThe World Health Organization (WHO) estimates that 3.5% of the population live with hepatitis B virus (HBV); migrants to Europe are disproportionately affected. UK birth dose HBV vaccination is limited to infants born to those living with HBV (LWHBV). High‐risk infants (high maternal infectivity, low birthweight) also receive HBV immunoglobulin (HBIG). The Family Hepatitis Clinic follows infants and those LWHBV working towards WHO goals of combating viral hepatitis by 2030.MethodsA trust‐wide electronic note review of outcomes for infants born to those LWHBV (2016–2020).ResultsTwo hundred and eighty‐three infants, 134 (47%) females, born to those LWHBV were referred. Two hundred and thirty‐one (82%) attended follow‐up with a vertical transmission rate of 0%. Twenty (7%) individuals LWHBV received tenofovir disoproxil fumerate in pregnancy; median viral load (VL) at initiation 125 416 376 DNA IU/mL, one having birth VL. Twenty‐eight (10%) infants were stratified as high risk and all received HBIG and birth dose vaccination with 9 (32%) subsequently lost to follow‐up, compared to 48 (19%) low‐risk infants. 267/283 (94%) had birth dose vaccination documented and 206/283 (73%) received at least four vaccine doses. 215/283 (76%) infants had serology by 24 months; 17 (6%) with suboptimal vaccine responses: hepatitis B surface antibody <100 IU/mL. Serology before 18 months resulted in higher rates of maternal hepatitis B core antibody detection (15% vs. 3%).ConclusionPrevention of vertical transmission of HBV was universal in those attending, although high‐risk infants were more likely lost to follow up. HBV post‐vaccine serological protection was comparable with national data from 2021 (77% >4 doses, 77% HBsAb >100).

2024-09-01·Transplantation

Efficacy of Newer Nucleos(t)ide Analogs After Hepatitis B Immunoglobulin Discontinuation Against Hepatitis B and D Recurrence in Liver Transplant Recipients

Article

作者: Oikonomou, Theodora ; Cholongitas, Evangelos ; Goulis, Ioannis ; Sinakos, Emmanouil ; Bafa, Konstantina ; Papatheodoridis, George V

Background.The use of nucleos(t)ide analogs (NAs) with a high genetic barrier to resistance, namely entecavir and tenofovir, has improved the efficacy of antiviral prophylaxis against hepatitis B virus (HBV) recurrence after liver transplantation (LT). However, the optimal duration and dosage of hepatitis B immunoglobulin (HBIG) administration, particularly in patients transplanted for HBV and hepatitis D virus (HDV) coinfection, remains controversial.Methods.We evaluated 28 patients transplanted for HBV/HDV cirrhosis. After LT, each patient received a fixed scheme of low-dose HBIG plus NA for 6 mo post-LT and then continued with long-term NA prophylaxis (entecavir: 8, tenofovir: 20 patients).Results.During 72 mo of follow-up, reappearance of hepatitis B surface antigen at low titers was observed in 1 (3.6%) patient at 33 mo after HBIG discontinuation, which became negative after a single dose of HBIG 1000 IU/L, whereas both serum HBV DNA and HDV RNA remained persistently undetectable and without any clinical or biochemical evidence of HBV/HDV recurrence.Conclusions.We showed for the first time the efficacy of a short, fixed scheme of low-dose HBIG plus NA followed by long-term NA monoprophylaxis against HBV/HDV recurrence after LT, although careful follow-up is needed after HBIG discontinuation, whereas further larger studies are needed to confirm these findings.

2024-06-01·Liver Transplantation

Low frequency of HBsAg reemergence in liver transplant recipients after stopping hepatitis B immune globulin: Implications for prophylaxis protocols

Article

作者: Terrault, Norah A ; Genyk, Yuri S ; Mayemura, Collin T ; Xu, Mimi ; Kong, Niwen ; Kahn, Jeffrey A

100 项与 HBIG 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	J06BB04	DB05276

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

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

未上市

10 条进展最快的记录,

登录

后查看更多信息

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	2004-11-01
慢性乙型肝炎	临床前	西班牙	Instituto Grifols SA	2003-10-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

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	艱夢夢鏇壓膚積繭鑰鏇(繭艱繭蓋夢醖鑰艱積繭) = 築鹹糧築夢遞簾顧膚壓範膚齋顧餘衊願膚齋鬱 (製構餘憲鑰糧艱壓築衊 ) 更多	积极	2020-08-27
				Combination treatments with antiviral prophylaxis and HBIG	艱夢夢鏇壓膚積繭鑰鏇(繭艱繭蓋夢醖鑰艱積繭) = 觸艱糧夢衊願網膚構憲範膚齋顧餘衊願膚齋鬱 (製構餘憲鑰糧艱壓築衊 ) 更多
EASL2019	N/A	乙型肝炎 HBeAg status \| maternal HBV DNA load	16,121	100 IU HBIG	構鬱醖憲艱衊觸襯廠選(製鹹壓積醖憲齋夢獵蓋) = 鑰餘鹽壓壓繭襯襯築鑰願蓋獵遞網鏇窪衊鬱範 (網選選鏇簾淵鬱壓鑰顧, 4% − 9%)	-	2019-04-13
				200 IU HBIG	構鬱醖憲艱衊觸襯廠選(製鹹壓積醖憲齋夢獵蓋) = 築遞蓋顧鹽顧製壓積築願蓋獵遞網鏇窪衊鬱範 (網選選鏇簾淵鬱壓鑰顧, 5% − 8%)
EASL2019	N/A	乙型肝炎	18	HBIG and NA therapy	顧獵鏇窪糧鹹網窪繭膚(窪壓積醖網壓糧觸顧膚) = 餘衊淵願鏇鹹繭鬱糧簾齋網憲顧醖繭憲獵繭觸 (膚窪醖鹹鏇憲夢壓鹹夢 ) 更多	-	2019-04-12
				NA therapy only	顧獵鏇窪糧鹹網窪繭膚(窪壓積醖網壓糧觸顧膚) = 鏇積築獵蓋蓋鏇築夢繭齋網憲顧醖繭憲獵繭觸 (膚窪醖鹹鏇憲夢壓鹹夢 ) 更多
NCT01131065 (CTgov)	临床3期	乙型肝炎	15	Hepatitis B immune globulin	齋鹽蓋窪鏇廠獵遞壓鹽(觸蓋衊鬱製簾艱餘醖構) = 鹽構齋醖艱襯選製夢網淵壓遞淵網鏇窪襯範壓 (繭壓餘鹹願構積範遞憲, 憲艱窪淵鬱遞願醖築積 ~ 鬱廠繭壓廠範鑰廠夢壓) 更多	-	2016-02-01