Delving into the Latest Updates on GlaxoSmithKline Manufacturing SpA with Synapse

Overview

本研究旨在确认Bepirovirsen 300 mg每周一次持续给药24周（含负荷剂量）相较于安慰剂组的有效性、安全性、PK特征以及HBsAg抑制的持久性。本研究的数据旨在确认Bepirovirsen用于慢性HBV感染受试者的有效性，并确立其安全性特征，为评估获益/风险关系、支持其上市批准提供充分的依据。

[Translation]

This study aims to confirm the efficacy, safety, PK characteristics and durability of HBsAg suppression of Bepirovirsen 300 mg once a week for 24 weeks (including loading dose) compared with the placebo group. The data of this study are intended to confirm the efficacy of Bepirovirsen in subjects with chronic HBV infection and establish its safety characteristics, providing sufficient basis for evaluating the benefit/risk relationship and supporting its marketing approval.

Start Date08 May 2023

Sponsor / Collaborator

GlaxoSmithKline Manufacturing SpA

[+2]

CTR20231004 / Active, not recruitingPhase 3

评估 Bepirovirsen 用于治疗核苷（酸）类似物经治的慢性乙型肝炎病毒感染受试者的有效性和安全性的 III 期、多中心、随机、双盲研究（BWell 2）

[Translation] A Phase III, multicenter, randomized, double-blind study to evaluate the efficacy and safety of bepirovirsen in subjects with chronic hepatitis B virus infection who have undergone nucleos(t)ide analog therapy (BWell 2)

本研究旨在确认Bepirovirsen 300 mg每周一次持续给药24周（含负荷剂量）相较于安慰剂组的有效性、安全性、PK特征以及HBsAg抑制的持久性。本研究的数据旨在确认Bepirovirsen用于慢性HBV感染受试者的有效性，并确立其安全性特征，为评估获益/风险关系、支持其上市批准提供充分的依据。

[Translation]

This study aims to confirm the efficacy, safety, PK characteristics and durability of HBsAg suppression of Bepirovirsen 300 mg once a week for 24 weeks (including loading dose) compared with the placebo group. The data of this study are intended to confirm the efficacy of Bepirovirsen in subjects with chronic HBV infection and establish its safety characteristics, providing sufficient basis for evaluating the benefit/risk relationship and supporting its marketing approval.

Start Date08 May 2023

Sponsor / Collaborator

GlaxoSmithKline Manufacturing SpA

[+2]

CTR20223135 / CompletedPhase 4

一项关于思福妥 ®在中国复杂性腹腔感染患者中的有效性、安全性和治疗模式的真实世界观察性研究

[Translation] A real-world observational study on the efficacy, safety and treatment patterns of Sefortuo® in Chinese patients with complicated intra-abdominal infections

本研究的目的是为了进一步评估思福妥在批准后的真实世界临床实践中的有效性、安全性和治疗模式

[Translation]

The purpose of this study is to further evaluate the efficacy, safety, and treatment patterns of Sefortox in real-world clinical practice after approval.

Start Date07 Apr 2023

Sponsor / Collaborator

Pfizer Investment Co. Ltd.

[+3]

100 Clinical Results associated with GlaxoSmithKline Manufacturing SpA

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0 Patents (Medical) associated with GlaxoSmithKline Manufacturing SpA

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100 Deals associated with GlaxoSmithKline Manufacturing SpA

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100 Translational Medicine associated with GlaxoSmithKline Manufacturing SpA

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Pipeline

Pipeline Snapshot as of 26 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Other

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