Delving into the Latest Updates on Human Hepatitis B Immunoglubolin (Tonrol Biological) with Synapse

Overview

Basic Info

Drug Type

Immunoglobulin

Synonyms-

Target-

Mechanism

Immunomodulators

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis B

Inactive Indication-

Originator Organization

Tonrol Biological Pharmaceutical Co. Ltd.

Active Organization

Tonrol Biological Pharmaceutical Co. Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (01 Jan 2002),

Hepatitis B

Regulation-

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主要目的：评价同路生物制药股份有限公司生产的冻干静注乙型肝炎人免疫球蛋白（pH4）联合拉米夫定预防乙型肝炎病毒（HBV）相关疾病肝移植患者术后HBV再感染的临床有效性。次要目的：评价冻干静注乙型肝炎人免疫球蛋白（pH4）的临床安全性。

[Translation]

Primary objective: To evaluate the clinical effectiveness of freeze-dried intravenous hepatitis B human immunoglobulin (pH4) produced by Tonglu Biopharmaceutical Co., Ltd. combined with lamivudine in preventing HBV reinfection after liver transplantation in patients with hepatitis B virus (HBV)-related diseases. Secondary objective: To evaluate the clinical safety of freeze-dried intravenous hepatitis B human immunoglobulin (pH4).

Start Date03 Jul 2014

Sponsor / Collaborator