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Last update 08 May 2025

HBcrAg

Last update 08 May 2025

Basic Info

Synonyms-

Introduction-

Drugs associated with HBcrAg

TVAX-008

Target

HBcrAg x L-HBsAg

Mechanism

HBcrAg inhibitors [+2]

Active Org.

Grand Theravac Life Science Nanjing Co. Ltd.

Originator Org.

Grand Theravac Life Science Nanjing Co. Ltd.

Active Indication

Hepatitis B, Chronic

Inactive Indication-

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date20 Jan 1800

Clinical Trials associated with HBcrAg

CTR20250030

/ Not yet recruitingPhase 2

一项评估 TVAX-008 注射液治疗慢性乙型肝炎有效性和安全性的多中心、随机、双盲、安慰剂平行对照Ⅱ期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of TVAX-008 injection in the treatment of chronic hepatitis B

主要目的：评价 TVAX-008 注射液的有效性。次要目的：评价 TVAX-008 注射液的安全性。探索性目的：探索实现功能性治愈[定义为实现血清 HBsAg 转阴（HBsAg<0.05 IU/mL）和血清乙型肝炎病毒脱氧核糖核酸（HBV DNA）<定量下限（LLOQ）]的受试者肝内 HBV 相关标志物。

[Translation]

Primary objective: To evaluate the efficacy of TVAX-008 injection. Secondary objective: To evaluate the safety of TVAX-008 injection. Exploratory objective: To explore the hepatic HBV-related markers in subjects who have achieved functional cure [defined as serum HBsAg negative conversion (HBsAg < 0.05 IU/mL) and serum hepatitis B virus deoxyribonucleic acid (HBV DNA) < lower limit of quantification (LLOQ)].

Start Date-

Sponsor / Collaborator

Grand Theravac Life Science Nanjing Co. Ltd.

CTR20231429

/ RecruitingPhase 2

在经治慢性乙型肝炎患者中评估 TVAX-008 注射液治疗有效性和安全性的多中心、随机、双盲、安慰剂平行对照II 期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of TVAX-008 injection in patients with previously treated chronic hepatitis B

主要目的：评价 TVAX-008 注射液治疗核苷（酸）类似物（NAs）经治的慢性乙型肝炎患者的有效性。次要目的：评价 TVAX-008 注射液治疗核苷（酸）类似物（NAs）经治的慢性乙型肝炎患者的安全性。

[Translation]

Primary objective: To evaluate the efficacy of TVAX-008 injection in the treatment of chronic hepatitis B patients who have been treated with nucleoside (acid) analogs (NAs). Secondary objective: To evaluate the safety of TVAX-008 injection in the treatment of chronic hepatitis B patients who have been treated with nucleoside (acid) analogs (NAs).

Start Date30 May 2023

Sponsor / Collaborator

Grand Theravac Life Science Nanjing Co. Ltd.

CTR20202547

/ CompletedPhase 1

TVAX-008注射液在慢性乙肝患者中的安全性,耐受性和药代动力学特征观察的I期临床试验

[Translation] A Phase I clinical trial to observe the safety, tolerability and pharmacokinetic characteristics of TVAX-008 injection in patients with chronic hepatitis B

主要研究目的:评估TVAX-008注射液的安全性,耐受性和药代动力学(PK)特征. 次要研究目的:评估TVAX-008注射液佐剂的安全性,耐受性和药代动力学(PK)特征. 探索性研究目的:1,初步观察TVAX-008注射液在慢性乙肝患者中的有效性. 2,探索与TVAX-008注射液疗效相关的免疫学标志物. 3,探索II期临床试验推荐用药剂量.

[Translation]

Main research objectives: To evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of TVAX-008 injection. Secondary research objectives: To evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of TVAX-008 injection adjuvant. Exploratory research objectives: 1. Preliminary observation of the effectiveness of TVAX-008 injection in patients with chronic hepatitis B. 2. To explore immunological markers related to the efficacy of TVAX-008 injection. 3. To explore the recommended dosage for Phase II clinical trials.

Start Date26 Jan 2021

Sponsor / Collaborator

Grand Theravac Life Science Nanjing Co. Ltd.

100 Clinical Results associated with HBcrAg

100 Translational Medicine associated with HBcrAg

0 Patents (Medical) associated with HBcrAg

281

Literatures (Medical) associated with HBcrAg

01 May 2025·The Lancet Gastroenterology & Hepatology

Hepatitis B core-related antigen rapid diagnostic test for point-of-care identification of women at high risk of hepatitis B vertical transmission: a multicountry diagnostic accuracy study

Article

Author: Sugiura, Wataru ; Yang, Jee-Seon ; Borand, Laurence ; Lunel-Fabiani, Françoise ; Schaeffer, Laura ; Hashimoto, Naofumi ; Sovann, Saren ; Miura, Tetsuo ; Tiendrebeogo, Abdoul Salam Eric ; Ségéral, Olivier ; Njouom, Richard ; Pivert, Adeline ; Koné, Amariane ; Tall, Haoua ; Vincent, Jeanne Perpétue ; Shimakawa, Yusuke ; Kania, Dramane ; Delvallez, Gauthier ; Sanou, Armel Moumouni ; Vray, Muriel ; Adoukara, Jean-Pierre ; Cloherty, Gavin ; Tanaka, Yasuhito

BACKGROUNDTimely administration of the hepatitis B virus (HBV) birth dose vaccine, along with identifying high-risk pregnant individuals for antiviral prophylaxis, is essential for the global elimination of vertical transmission of HBV. However, in resource-limited settings, access to HBV DNA testing is scarce, and accurate rapid tests for HBeAg are lacking. We aimed to assess the diagnostic performance of a newly developed hepatitis B core-related antigen (HBcrAg) rapid diagnostic test (RDT) to identify women who are HBsAg-positive and eligible for antiviral prophylaxis.METHODSIn this multicountry diagnostic accuracy study, we retrospectively validated the HBcrAg-RDT using stored plasma from pregnant women who were HBsAg-positive in cohort studies from Cambodia and Cameroon and prospectively using finger-prick capillary blood from postpartum mothers at rural health centres in Burkina Faso. We estimated the sensitivity and specificity of the HBcrAg-RDT for diagnosing high HBV DNA concentrations (≥200 000 IU/mL) using real-time PCR (rtPCR) as the reference. We compared the diagnostic performance of the HBcrAg-RDT with that of conventional HBeAg assays based on the area under the receiver operating characteristic curve (AUROC).FINDINGSIn total, plasma samples were available for 1964 participants: 1194 stored plasma samples available for analysis from the Cambodian cohort, 501 stored samples from the Cameroonian cohort, and 269 prospectively collected samples from women in the Burkina Faso cohort. In the pooled population, the mean age was 28·1 years (SD 6·0), and 382 (20·0%) were HBeAg positive. The HBcrAg-RDT showed an overall sensitivity of 93·1% (95% CI 90·5-95·2) and specificity of 94·3% (93·0-95·4). Sensitivity and specificity were 93·4% (90·7-95·5) and 94·4% (92·9-95·6) in the retrospective laboratory-based analyses of samples from Cambodia and Cameroon, and 89·7% (75·8-97·1) and 93·9% (90·0-96·6) in the prospective real-world analysis of samples of HBsAg-positive women from Burkina Faso. The AUROC for HBcrAg-RDT (0·937 [95% CI 0·924-0·950]) in distinguishing high versus low HBV DNA concentrations at the 200 000 IU/mL threshold in the pooled data set was significantly higher than that of HBeAg rapid tests (0·822 [0·798-0·845]; p<0·0001) and similar to laboratory-based HBeAg immunoassays (ELISA and chemiluminescence assay; 0·926 [0·897-0·955]; p=0·72). In Burkina Faso, the median turnaround time for HBV DNA testing was 46 days (IQR 31-72), whereas HBcrAg-RDT provided same-day results for all participants.INTERPRETATIONHBcrAg-RDT might offer a practical solution for integrating the prevention of vertical transmission of HBV into decentralised antenatal care in resource-limited settings, enabling timely identification and management of pregnant individuals who are at high risk of transmission.FUNDINGAgence Nationale de Recherches sur le Sida et les Hépatites Virales, Total Foundation, Gilead Sciences, and Japan Society for the Promotion of Science.TRANSLATIONFor the French translation of the abstract see Supplementary Materials section.

01 May 2025·The Lancet Gastroenterology & Hepatology

Preventing vertical transmission of HBV in LMICs: what could HBcrAg rapid tests add?

Article

Author: Stockdale, Alexander ; Adda, Danjuma

01 May 2025·Liver International

HBcrAg and cirB‐RNA Do Not Predict Clinical and Virological Outcomes in Patients With HBeAg‐Negative Chronic Infection

Article

Author: Lens, Sabela ; Pérez‐del‐Pulgar, Sofía ; Cortese, Maria Francesca ; Rodrìguez‐Tajes, Sergio ; Battistella, Sara ; Mariño, Zoe ; Hurtado, Juan Carlos ; Leonel, Thais ; Rando‐Segura, Ariadna ; Tabernero, David ; Pocurull, Anna ; Saez‐Palma, Maria ; Forns, Xavier

ABSTRACTBackground & AimsPredicting clinical and virological outcomes in HBeAg‐negative (HBeAg‐neg) chronic infection often requires long‐term monitoring. Our study explored whether a single measurement of quantitative HBsAg (qHBsAg), HBV core‐related antigen (HBcrAg), and circulating HBV RNA (cirB‐RNA) can define the natural course of untreated HBeAg‐neg chronic infection patients.MethodsTo this aim, we included 128 naïve HBeAg‐neg chronic infection patients, stratified according to qHBsAg levels in: (1) 10–1000 IU/mL, (2) 1000–10 000 IU/mL, and (3) > 10 000 IU/mL.ResultsHBcrAg and cirB‐RNA were detected in 27% and 19% of patients with qHBsAg > 1000 IU/mL but rarely detected in patients with qHBsAg < 1000 IU/mL. After a median follow‐up of 5.1 years, 9.4% of patients lost HBsAg, and 8.5% experienced an increase in HBV DNA > 2000 IU/mL. qHBsAg < 1000 IU/mL was the only factor independently associated with functional cure.ConclusionsIn untreated HBeAg‐neg chronic infection patients, single‐point cirB‐RNA and HBcrAg do not offer additional predictive value over qHBsAg < 1000 IU/mL for spontaneous HBsAg loss.

News (Medical) associated with HBcrAg

23 Apr 2025

·investor.arbutusbio.com

Arbutus to Present Imdusiran and AB-101 Data at EASL Congress 2025

Five abstracts accepted for poster presentations WARMINSTER, Pa., April 23, 2025 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company focused on infectious disease, today announced that five abstracts, including one late-breaker, have been accepted for presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7 - 10, 2025 in Amsterdam, Netherlands. The following abstracts will be presented as posters in the Viral Hepatitis B and D: New Therapies, Unapproved Therapies or Strategies session on May 8, 2025, from 8:30 am – 5:00 pm CET. Abstract Number: 1768 Title: IM-PROVE I: characterization of chronic hepatitis B (CHB) subjects with functional cure or HBV DNA suppression after completion of imdusiran plus short courses of pegylated interferon alfa-2a (IFN) and discontinuation of nucleos(t)ide analogue (NA) therapy Presenter: Prof. Man-Fung Yuen Presentation Date: May 8, 2025 Key Findings: Within this small group of subjects who achieved functional cure or HBV DNA

Clinical ResultPhase 2siRNA

26 Mar 2025

·www.globenewswire.com

Aligos Therapeutics Presents Positive Data at APASL 2025

SOUTH SAN FRANCISCO, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced positive data from three oral presentations at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2025, being held March 26 - 30, 2025 in Beijing, China. “We are pleased to present preliminary data out to 96 weeks in our Phase 1 study of ALG-000184, which continues to demonstrate first-/best-in-class reductions in important HBV markers,” stated Lawrence Blatt, PhD, MBA, Chairman, President, & CEO of Aligos Therapeutics. “Additionally, the HERALD data from the Phase 2a study of ALG-055009 in MASH subjects demonstrated robust reductions in liver fat, with a subgroup analysis in subjects on stable GLP-1 agonist therapy, showing a potential role for ALG-055009 in combination with other therapies.” Two oral presentations will highlight the continued potent antiviral activity of ALG-000184 for chronic hepatitis B virus (HBV) infection in both HBeAg-positive and HBeAg-negative subjects, demonstrating the potential for the molecule to become first-line therapy for chronic suppression and the backbone for regimens aimed at functional cure. Data from ≤84 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated HBV DNA suppression (

Clinical ResultPhase 2Phase 1

19 Nov 2024

·www.globenewswire.com

Aligos Therapeutics Presents Positive Data at The Liver Meeting (TLM) 2024

SOUTH SAN FRANCISCO, Calif., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced positive data from one late-breaker oral and three poster presentations at the American Association for the Study of Liver Disease’s (AASLD) The Liver Meeting (TLM) 2024, being held November 15 – 19, 2024 in San Diego, CA. The clinical poster presentation highlighted the continued potent antiviral activity of ALG-000184 for chronic hepatitis B (CHB) virus infection in both HBeAg-positive and HBeAg-negative subjects, demonstrating the potential for the molecule to become first-line therapy for chronic suppression and the backbone for regimens aimed at functional cure. Data from ≤84 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated sustained HBV DNA suppression (

Clinical ResultPhase 2

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