[Translation] A single-center, randomized, open-label, single-dose, two-period crossover design bioequivalence study in healthy subjects in the fasting state

本试验以正大天晴药业集团股份有限公司生产的马来酸恩替卡韦片和Bristol-Myers Squibb Company生产的Baraclude，进行空腹单剂量给药的人体生物等效性评价，为其临床评价及临床用药提供参考;并观察受试制剂马来酸恩替卡韦片和参比制剂（Baraclude）在健康受试者中的安全性。

[Translation]

This study used Entecavir Maleate Tablets produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Baraclude produced by Bristol-Myers Squibb Company to evaluate the bioequivalence of single-dose administration on an empty stomach in humans, to provide a reference for their clinical evaluation and clinical use; and to observe the safety of the test preparation Entecavir Maleate Tablets and the reference preparation (Baraclude) in healthy subjects.

Start Date02 May 2018

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

NCT01724723 / Unknown statusPhase 4IIT

Prophylactic Use of Entecavir to Reduce Hepatitis Flare in Highly Viremic HBV Patients With Active Tuberculosis Receiving Anti-tuberculous Treatment

Hepatitis during anti-tuberculous treatment (HATT) has been an obstacle in managing TB patients, especially in those with viral hepatitis. A previous study revealed the risk of HATT is significantly higher in TB patients with high serum hepatitis B virus (HBV) DNA level than those with low HBV DNA level. Based on these findings, we thus hypothesize that the risk of HATT in TB patients with high baseline serum HBV DNA level can be reduced by concomitant use of anti-HBV agent. In this proposal, we will conduct a prospective randomized clinical study to assess the reduction of HATT risk by using entecavir in TB patients with high baseline serum HBV DNA level, and to evaluate the risk of other treatment-related adverse events in two hospitals.

Start Date01 Dec 2012

Sponsor / Collaborator

National Taiwan University Hospital

NCT01926288 / CompletedPhase 4

Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B

The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets in Chinese patients with hepatitis B

Start Date01 Oct 2008

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Entecavir Maleate

100 Translational Medicine associated with Entecavir Maleate

100 Patents (Medical) associated with Entecavir Maleate

Literatures (Medical) associated with Entecavir Maleate

01 Oct 2022·Journal of Viral Hepatitis

240‐week entecavir maleate treatment in Chinese chronic hepatitis B predominantly genotype B or C

Article

Author: Zhang, Da‐Zhi ; Xie, Qing ; Xu, Jing‐Hang ; Tang, Hong ; Dai, Jun ; Mao, Qing ; Yu, Yan‐Yan ; Zhang, Xi‐Quan ; Zeng, Zheng ; Fan, Ya‐Nan ; Sheng, Ji‐Fang ; Li, Jun ; Xu, Zhong‐Nan ; Ning, Qin ; Si, Chong‐Wen ; Shi, Guang‐Feng ; Chen, Xin‐Yue

AbstractThis study aimed to evaluate the efficacy and safety of entecavir(ETV) versus ETV maleate in Chinese patients with chronic hepatitis B(CHB). This was a randomized, double‐blind, double‐dummy, controlled, multicentre study. Patients were randomly assigned to receive 48 weeks of treatment with 0.5 mg/day ETV (group A) or 0.5 mg/day ETV maleate (group B), then, all patients received treatment with 0.5 mg/day ETV maleate from week 49 onwards. Patients were regularly followed up. Serum hepatitis B virus (HBV) markers were detected. Adverse events (AE) were recorded. The primary endpoint was the decline in HBV DNA in each group at the end of treatment. Secondary endpoints included the rate of HBV DNA below the lower limit of detection (LLOD) (20 I U/ml) at the end of treatment, the rate of hepatitis B e antigen (HBeAg) loss, the rate of HBeAg seroconversion and serum alanine aminotransferase (ALT) normalization. One hundred and thirty‐seven (71 in group A) patients with HBeAg‐positive CHB and 46 (21 in group A) patients with HBeAg‐negative CHB completed the 240‐week treatment and follow‐up. Baseline characteristics were well balanced between the two groups. For the HBeAg‐positive CHB patients, the mean HBV DNA level had similarly decreased from baseline in both groups (A: by 6.67 log10 IU/ml vs. B: by 6.74 log10 IU/ml; p > .05) at Week 240. Patients who achieved undetectable levels of serum HBV DNA (<20 IU/ml) at Week 240 were similar between groups (A:91.55% vs. B:87.88%; p > .05). Both groups achieved similar HBeAg seroconversion rates at week 240 (A:26.98% vs. B:20.97%; p > .05). Both groups achieved similar normalization of ALT (A:87.32% vs. B:83.61%; p > .05) at Week 240 (p > .05). For the HBeAg‐negative CHB patients, the mean HBV DNA level had similarly decreased from baseline in both groups (A: by 6.05 log10 IU/ml vs. B: by 6.10 log10 IU/ml; p > .05) at Week 240. Patients who achieved undetectable levels of serum HBV DNA at Week 240 were similar between groups (A:100% vs. B:100%). Both groups achieved similar normalization rates (A:90.91% vs. B: 95.45%; p > .05) of ALT at Week 240 (p > .05). In conclusion, long‐term ETV maleate treatment was safe and efficient in Chinese CHB predominantly of genotype B or C.

01 Oct 2017·Journal of Viral HepatitisQ2 · MEDICINE

Entecavir maleate versus entecavir in Chinese chronic hepatitis B predominantly genotype B or C: Results at week 144

Q2 · MEDICINE

Article

Author: Xie, Q. ; Tang, H. ; Si, C.‐W. ; Ning, Q. ; Xu, J.‐H. ; Shi, G.‐F. ; Xu, Z.‐N. ; Zeng, Z. ; Zhang, D.‐Z. ; Dai, J. ; Mao, Q. ; Sheng, J.‐F. ; Li, J. ; Yu, Y.‐Y. ; Wang, S. ; Chen, X.‐Y. ; Zhang, X.‐Q.

SummaryReports on the efficacy and safety of long‐term entecavir treatment in chronic hepatitis B (CHB) predominantly genotype B or C are insufficient. This study presents the efficacy and safety of entecavir maleate in Chinese CHB patients. Patients were randomly assigned to receive 48‐week treatment with either 0.5 mg/day entecavir (group A) or 0.5 mg/day entecavir maleate (group B), and then all patients received treatment with 0.5 mg/day entecavir maleate from week 49. Two hundred and seventy‐five patients with CHB (HBeAg‐positive: 218) were analysed, predominantly (98.5%) with genotype B or C. Baseline characteristics were balanced. For the HBeAg‐positive CHB patients, the mean HBV DNA level decreased similarly (A: by 6.36 log10IU/mL vs B: by 6.31 log10IU/mL) between groups at week 144. The percentages of patients who achieved undetectable HBV DNA were similar (A: 70.59% vs B: 66.67%) between groups. Similar HBeAg loss rates (A: 43.53% vs B: 40.23%; P>.05) and HBeAg seroconversion rates (A: 21.52% vs B: 21.18%) were achieved. For the HBeAg‐negative CHB patients, similar reductions in HBV DNA levels from baseline (A: by 6.13 log10IU/mL vs B: by 5.65 log10IU/mL) and percentages of patients who achieved undetectable HBV DNA (A: 100% vs B: 100%) were achieved. The overall incidence of adverse events was comparable between groups. In conclusions, 48‐week administration of entecavir maleate and entecavir showed similar efficacy and safety in Chinese patients with CHB. Long‐term entecavir maleate treatment was effective and safe in CHB patients.

01 Feb 2017·Journal of Viral HepatitisQ2 · MEDICINE

Baseline hepatitis B core antibody predicts treatment response in chronic hepatitis B patients receiving long‐term entecavir

Q2 · MEDICINE

Article

Author: Wang, S. ; Mao, Q. ; Li, N. ; Sheng, J.‐F. ; Si, C.‐W. ; Xu, J.‐H. ; Chen, X.‐Y. ; Yuan, Q. ; Song, L.‐W. ; Shi, G.‐F. ; Xia, N.‐S. ; Xie, Q. ; Tang, H. ; Zeng, Z. ; Yu, Y.‐Y. ; Ning, Q. ; Zhang, D.‐Z. ; Li, J.

SummaryStudies regarding the clinical significance of quantitative hepatitis B core antibody (anti‐HBc) in patients with chronic hepatitis B receiving first‐line nucleos(t)ide analogues is limited. The aim of this study was to determine the performance of anti‐HBc as a predictor for hepatitis B e antigen (HBeAg) seroconversion in HBeAg‐positive CHB patients treated with entecavir. This was a retrospective cohort study consisting of 139 Chinese patients enrolled in a multicenter clinical trial treated with entecavir or entecavir maleate for up to 240 weeks. Anti‐HBc evaluation was conducted for all the available samples using a newly developed double‐sandwich anti‐HBc immunoassay. At week 240, 35 (25.2%) patients achieved a serological response (HBeAg seroconversion) and these patients at week 240 had significantly higher levels of anti‐HBc (P<.01). We defined 4.65 log10 IU·mL−1, with a maximum sum of sensitivity and specificity, as the optimal cut‐off value of baseline anti‐HBc level to predict seroconversion. Patients with baseline anti‐HBc ≥4.65 log10 IU·mL−1 had 28.0% (26/93) and 35.5% (33/93) chance of seroconversion at weeks 144 and 240, respectively. The baseline anti‐HBc level was the strongest predictor for seroconversion at week 144 (OR: 5.78, 95% confidence interval [CI]: 2.05‐16.34, P=.001). The baseline anti‐HBc level was a strong predictor for seroconversion at week 240 (OR: 5.36, 95% CI: 2.17‐13.25, P<.001). Hence, baseline anti‐HBc titre is a useful predictor of long‐term entecavir therapy efficacy in HBeAg‐positive CHB patients, which could be used to optimize antiviral therapy.

100 Deals associated with Entecavir Maleate

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R&D Status

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Indication	Country/Location	Organization	Date
Hepatitis B	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Jun 2012

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01926288 (Pubmed \| J Viral Hepat)	Phase 4	Hepatitis B, Chronic	287	Entecavir	jnkdmfepey(cnymmunima) = glihpwdwlm uyznyumdje (zqevpanbkz ) View more	-	01 Oct 2017
				Entecavir maleate	jnkdmfepey(cnymmunima) = ndroawkhdr uyznyumdje (zqevpanbkz ) View more

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