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.

Start Date01 Dec 2016

Sponsor / Collaborator

University of Arizona

NCT02901418

/ Unknown statusNot ApplicableIIT

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.

Start Date01 Jul 2015

Sponsor / Collaborator

Beijing Ditan Hospital

NCT02417207

/ Unknown statusPhase 4IIT

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.

Start Date01 Apr 2015

Sponsor / Collaborator

The Third Affiliated Hospital, Sun Yat-Sen University

100 Clinical Results associated with Hepatitis B Immune Globulin(Grifols)

100 Translational Medicine associated with Hepatitis B Immune Globulin(Grifols)

100 Patents (Medical) associated with Hepatitis B Immune Globulin(Grifols)

1,084

Literatures (Medical) associated with Hepatitis B Immune Globulin(Grifols)

01 Mar 2025·JHEP Reports

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

Article

Author: 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.

04 Feb 2025·JAMA

A Randomized Clinical Trial

Article

Author: 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

01 Jan 2025·Hepatology Research

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

Article

Author: 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.

100 Deals associated with Hepatitis B Immune Globulin(Grifols)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J06BB04	DB05276

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis B	Spain	Grifols SA	01 Jan 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B	Preclinical	Italy	Instituto Grifols SA	01 Jul 2010
Hepatitis B, Chronic	Preclinical	Spain	Instituto Grifols SA	01 Oct 2003

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EASL2020	Not Applicable	Hepatitis B HBsAg-positive \| anti-HBc positive	1,355	HBIG monotherapy	alhzdoyiow(rxobnmpvhe) = qaijxlqvqh xpoqatiatd (rvzdbfljou ) View more	Positive	27 Aug 2020
				Combination treatments with antiviral prophylaxis and HBIG	alhzdoyiow(rxobnmpvhe) = gabzhwhbxe xpoqatiatd (rvzdbfljou ) View more
EASL2019	Not Applicable	Hepatitis B HBeAg status \| maternal HBV DNA load	16,121	100 IU HBIG	lklyrxxyiw(gkzjyzjjba) = nrfmysxknr thvkkdfcba (yqkwuciciw, 4% − 9%)	-	13 Apr 2019
				200 IU HBIG	lklyrxxyiw(gkzjyzjjba) = ujrdzjyuik thvkkdfcba (yqkwuciciw, 5% − 8%)
EASL2019	Not Applicable	Hepatitis B	18	HBIG and NA therapy	qqgmlwgako(tthpqgfjlm) = emngvhbfky tifokxwydb (kyujdyifim ) View more	-	12 Apr 2019
				NA therapy only	qqgmlwgako(tthpqgfjlm) = udngrrweui tifokxwydb (kyujdyifim ) View more
NCT01131065 (CTgov)	Phase 3	Hepatitis B	15	Hepatitis B immune globulin	rubjezrbbo(xshwqvzppy) = jwoigzefbf jvlupcjtkv (srskfdwewr, luwfrlvsiu - vkxtzsqssu) View more	-	01 Feb 2016

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