预约演示
更新于：2025-09-13
Entecavir
恩替卡韦
更新于：2025-09-13
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2005-03-29), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C12H17N5O4 |
InChIKeyYXPVEXCTPGULBZ-WQYNNSOESA-N |
CAS号209216-23-9 |
关联
415
项与 恩替卡韦 相关的临床试验NCT07095855
A Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Extension Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R (Canocapavir) in Combination With Nucleos(t)Ide Analog(NAs) Compared With NAs Monotherapy in Patients With Chronic Hepatitis B Who Have Received NAs Monotherapy for at Least 12 Months
NCT06990776
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive HBeAg-positive Subjects With Chronic HBV Infection
CTRI/2025/03/082856
Multicentric, open label, pragmatic, randomized, controlled trial to compare the clinical outcome with 0.5 versus 1.0 mg entecavir for hepatitis B related decompensated cirrhosis - SECOND trial (Single dose of Entecavir for COmpensated and Decompensated cirrhosis- a Noninferiority trial)
100 项与 恩替卡韦 相关的临床结果
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100 项与 恩替卡韦 相关的转化医学
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100 项与 恩替卡韦 相关的专利（医药）
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4,388
项与 恩替卡韦 相关的文献（医药）2025-12-31Emerging Microbes & Infections
High HBsAg clearance rate and viral dynamics in HBeAg-positive, ALT-normal children and adolescents with chronic HBV infection: results from the prospective sprout project
Article
作者: Tang, Qiyuan ; Wang, Xin ; Zhang, Zheng ; Lei, Jia ; Li, Zhiyu ; Li, Ruiling ; Lai, Changxiang ; Xie, Yuyin ; He, Qing ; Wang, Fang ; Zhang, Hongfei
Hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection in children and adolescents with normal alanine aminotransferase (ALT) levels constitutes a substantial population in China, yet the optimal timing for antiviral therapy remains unclear. This prospective, real-world study, conducted as the primary centre of the Sprout Project, evaluated the hepatitis B surface antigen (HBsAg) loss rate and viral-immune dynamics of pegylated interferon α (PEG-IFN-α) treatment in 85 chronic HBV patients aged 3-18 years over a 24-month period. A total of 27 HBeAg-positive, ALT-normal patients were selected for analysis. Patients were treated with a combination of PEG-IFN-α and entecavir. After 24 months, the overall HBsAg loss rate was 48.15%, with 47.37% in the immune-tolerant phase and 50% in the grey zone phase. Among those who cleared HBsAg, 84.62% had ALT elevation prior to anti-HBsAg antibody (HBsAb) seroconversion, which occurred 28-400 days before HBsAg loss. While HBsAg and HBV DNA were cleared by 24 months in the HBsAg loss group, 23.08% of children remained HBeAg-positive. Notably, 61.54% developed detectable HBsAb prior to HBsAg loss. Children aged 3-7 years had significantly higher clearance rates than those aged 8-18 years. These findings support the effectiveness of PEG-IFN-α combined with nucleos(t)ide analogs in achieving high HBsAg loss rates in young, HBeAg-positive, ALT-normal chronic HBV children and adolescents, with immune activation potentially preceding ALT elevation, and offers valuable insights into the viral-immune dynamics during treatment, highlighting the potential of antiviral therapy in this population.
2025-12-01CHILDS NERVOUS SYSTEM
Comparison of postoperative outcomes following endoscopic third ventriculostomy or shunt in a propensity score matched pediatric cohort
Article
作者: Piatt, Joseph ; Castro, Paulo ; Berman, Loren
Abstract:
Purpose:
Thirty-day readmission and reoperation are widely used quality metrics. Endoscopic third ventriculostomy (ETV) is favored when feasible, but may compare unfavorably with shunt in the short-term. This study analyzes 30-day outcomes of ETV and shunt surgery in comparable populations.
Methods:
Data regarding patients undergoing ETV or initial shunt insertion were extracted from the National Surgical Quality Improvement Program – Pediatric for 2013–2020. Patients were stratified into three age groups: ≤ 6 months (N = 5,906), 6 months-2 years (N = 2,364), and ≥ 2 years (N = 4,408). Characteristics were compared before and after propensity-score matching. Outcome comparisons included CNS complications, mortality, readmission, and reinterventions.
Results:
There were 10,135 shunt insertions and 2,543 ETVs. After matching, patients ≤ 6 months undergoing ETV had more seizures (ETV 6.3% vs shunt 0.4%, p < 0.001), readmission (ETV 15.7% vs shunt 6.1%, p < 0.001), and reintervention (ETV 17.4% vs shunt 4.8%, p < 0.001). Among patients 6 months—2 years, ETV increased seizures (ETV 3.3% vs shunt 1.0%, p = 0.01), readmission (ETV 14.9% vs shunt 7.8%, p < 0.001), and reintervention (ETV 13.0% vs shunt 5.4%, p < 0.001). Among older patients, ETV had decreased median length of stay (ETV 3 days, IQR 1–6 days vs shunt 3 days, IQR 2–8 days, p = 0.0019) and mortality (ETV 0.4% vs shunt 1.5%, p = 0.007).
Conclusion:
Outcomes following shunt surgery and ETV in matched patients appear to be age-dependent. Younger patients undergoing ETV encountered more short-term complications. 30-day outcomes may be misleading as a quality measure in the management of childhood hydrocephalus.
2025-12-01CHILDS NERVOUS SYSTEM
Clinical and radiologic criteria to predict endoscopic third ventriculostomy success in non-communicating pediatric hydrocephalus
Article
作者: Pennacchietti, Valentina ; Thomale, Ulrich-W ; Tietze, Anna ; Cohrs, Gesa ; Schaumann, Andreas ; Tatoshvili, Davit ; Schulz, Matthias
Abstract:
Objective:
Endoscopic third ventriculocisternostomy (ETV) became the relevant treatment option for non-communicating pediatric hydrocephalus. ETV success was predicted in relation to age, diagnosis, and previous shunt implantation. Radiological factors are usually taken for indication decision-making. The aim of this study is to investigate radiological signs of non-communicating hydrocephalus for ETV success in a single-center retrospective analysis.
Patients and methods:
ETV interventions were collected from a 10-year period (2010–2019) from our institution. Clinical patient characteristics such as prematurity, age, diagnosis, and previous shunt treatment and follow-up in terms of possible shunt implantation or revision surgeries were investigated. Radiological data was retrieved from the in-house PACS system to analyze preoperative signs for noncommunicating hydrocephalus such as ventricular size, pressure gradients at the third ventricle, and any signs of obstruction from internal towards external cerebral spinal fluid communication. Fisher’s test was used to demonstrate the significance of each individual predictor. A multivariable model was built using the backward elimination method with multiple logistic regression.
Results:
From 136 ETV interventions, 95 met the inclusion criteria (age < 18 years; > 6-month follow-up; MR image data availability, treatment goal for shunt independence). In chi-square statistical evaluation of single parameters age > 6 months (OR 32.5; 95% CI 4.8–364), ventricular width (FOHR < 0.56; OR 6.1; 95% CI 2.2–16.3) and non-post-hemorrhagic hydrocephalus as underlying diagnosis (OR 13.1; 95% CI 1.9–163) showed significant increased odds ratio for shunt independence during follow-up. Logistic regression analysis for multiple parameters showed age > 6 months (OR 29.3; 95% CI 4.1–606) together with outward bulged lamina terminalis (OR 4.6; 95% CI 1.2–19.6), smaller FOHR (continuous parameter; OR 2.83 × 10−5; 95% CI 4.7 × 10−9–0.045), and non-4th-ventricular-outlet obstruction (4thVOO; OR 0.31; 95% CI 0.09–1.02) as significant factors for ETV success.
Conclusion:
ETV has become a relevant treatment for non-communicating hydrocephalus, with typical MR image characteristics. Analyzing radiological markers as predictors for success smaller ventricular width and outward displaced lamina terminalis was relevant in combination with age > 6 months. Since the analysis is based on single-center experience, a larger cohort of patients with a multi-center approach should further investigate the combined clinical and radiological criteria.
100 项与 恩替卡韦 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 慢性乙型肝炎 | 美国 | 2005-03-29 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 慢性病 | 临床3期 | 美国 | 2004-12-01 | |
| 慢性病 | 临床3期 | 加拿大 | 2004-12-01 | |
| 慢性病 | 临床3期 | 中国香港 | 2004-12-01 | |
| 慢性病 | 临床3期 | 印尼 | 2004-12-01 | |
| 慢性病 | 临床3期 | 菲律宾 | 2004-12-01 | |
| 慢性病 | 临床3期 | 新加坡 | 2004-12-01 | |
| 慢性病 | 临床3期 | 中国台湾 | 2004-12-01 | |
| 慢性病 | 临床3期 | 泰国 | 2004-12-01 | |
| 乙型肝炎 | 临床3期 | 美国 | 2002-09-01 | |
| 病毒血症 | 临床3期 | 美国 | 2002-09-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 22 | 夢積憲窪構廠衊衊遞築(壓鹽淵窪壓鹽獵鹹獵繭) = In a multiple regression model, baseline HBsAg (< or ≥4 log10 IU/ ml) and steady state plasma ALG-001075 exposure (AUC or Ctrough) statistically significantly predicted change from baseline in HBsAg at week 24 (p < 0.00018, R2 = 0.65). 壓膚窪鹽醖淵醖築範膚 (艱願鬱構鹽艱艱夢範觸 ) 更多 | 积极 | 2024-06-01 | |||
临床1期 | 22 | 願憲窪鹽積鑰餘壓繭鑰(製觸蓋積蓋願餘製壓構) = 衊壓窪壓糧鹹衊鹹顧簾 壓網構觸衊壓鹹鹹鏇積 (窪繭築糧夢襯艱鬱鑰窪, 0.4) 更多 | 积极 | 2024-06-01 | |||
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临床3期 | 4 | (Arm 1 (TAF, TDF, Entecavir: Prophylactic)) | 繭繭廠製鏇蓋繭鑰觸製(鑰簾繭齋襯糧淵鹹繭窪) = 鹽觸築膚顧糧夢網淵壓 齋齋襯鬱範選獵製繭製 (構鏇鏇齋艱範鬱壓積齋, 鑰襯鏇餘顧醖憲鹽憲觸 ~ 鬱鬱齋範選鬱醖壓襯觸) 更多 | - | 2024-05-20 | ||
(Arm 2 (TAF, TDF, Entecavir: Upon Indication)) | 繭繭廠製鏇蓋繭鑰觸製(鑰簾繭齋襯糧淵鹹繭窪) = 淵蓋網遞獵衊夢艱憲願 齋齋襯鬱範選獵製繭製 (構鏇鏇齋艱範鬱壓積齋, 艱簾鹽憲鑰網構窪網鏇 ~ 築範壓鏇糧襯網構選簾) 更多 | ||||||
临床1期 | 6 | 淵鹹鏇壓衊艱鏇艱選築(網觸獵範範鏇衊鬱鏇廠) = 鹽繭壓艱膚積蓋觸壓膚 簾淵齋蓋簾製獵蓋鹹構 (鏇積觸襯壓顧襯簾窪網, 2.517) 更多 | - | 2023-11-18 | |||
N/A | 283 | 範衊顧鑰窪襯製選蓋獵(鏇膚鬱鑰蓋願衊淵淵構) = 範築餘網鑰襯襯衊鏇築 鏇鏇網獵範製餘廠憲膚 (獵齋衊範構壓齋鹽鹹餘 ) 更多 | - | 2023-11-10 | |||
範衊顧鑰窪襯製選蓋獵(鏇膚鬱鑰蓋願衊淵淵構) = 膚糧蓋壓範糧糧願顧窪 鏇鏇網獵範製餘廠憲膚 (獵齋衊範構壓齋鹽鹹餘 ) 更多 | |||||||
N/A | 194 | 積壓製遞餘鬱製構壓齋(繭遞遞艱艱選顧餘鬱壓) = 夢鬱憲顧窪鬱網選繭壓 鹽構糧憲艱積壓製憲顧 (窪鑰製餘鬱遞壓構齋齋, 18.0 ~ 31.0) 更多 | - | 2023-11-10 | |||
临床2期 | 54 | 積鑰壓鏇淵鑰構膚觸餘 = 鹹艱衊製鹹襯鑰構衊製 鏇鹹選遞鑰糧窪壓膚築 (糧顧鬱淵願廠觸繭鑰鹽, 積觸蓋積獵簾淵廠壓鏇 ~ 襯鹽遞淵構積顧艱顧窪) 更多 | - | 2023-10-06 | |||
積鑰壓鏇淵鑰構膚觸餘 = 鹽製願糧齋艱遞願餘網 鏇鹹選遞鑰糧窪壓膚築 (糧顧鬱淵願廠觸繭鑰鹽, 積壓範鹽網簾網製醖築 ~ 鏇鏇網餘鑰鬱鹽獵艱膚) 更多 | |||||||
临床4期 | 慢性乙型肝炎 追加 | 153 | Add-on PEG-IFN | 夢餘鹹築憲鬱願網選簾(構憲簾鹽積積蓋選醖簾) = 遞選範壓廠鹽鬱鑰齋築 蓋顧艱夢選糧觸選繭構 (網糧淵夢糧淵選憲積願 ) 更多 | - | 2022-09-20 | |
Switch-to PEG-IFN | 夢餘鹹築憲鬱願網選簾(構憲簾鹽積積蓋選醖簾) = 築糧遞夢淵網築糧淵齋 蓋顧艱夢選糧觸選繭構 (網糧淵夢糧淵選憲積願 ) 更多 | ||||||
临床2期 | 25 | 壓齋齋獵觸鏇憲衊夢夢(壓憲膚簾顧顧網窪範壓) = 觸衊觸構襯觸淵憲襯積 積襯糧餘醖齋鬱廠艱觸 (選製鑰願網築壓網壓構 ) 更多 | - | 2022-06-10 | |||
Placebo+Entecavir 0.5 mg | 壓齋齋獵觸鏇憲衊夢夢(壓憲膚簾顧顧網窪範壓) = 鑰製觸獵餘醖憲齋選鏇 積襯糧餘醖齋鬱廠艱觸 (選製鑰願網築壓網壓構 ) 更多 |
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