通用名称

tenofovir disoproxil fumarate

儿科标签批准日期

2018/12/11 0:00:00

特定指示/秒

Chronic hepatitis B (CHB) in pediatric patients 2 years and older weighing at least 10 kg

标签更改摘要

- Safety and effectiveness in pediatric patients 2 years to less than 18 years of age is supported by data from two randomized trials in which Viread was administered to HBV-infected treatment-experienced patients. - Safety and effectiveness in chronic HBV-infected pediatric patients younger than 2 years and weighing less than 10 kg have not been established. - The effects of Viread-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in chronic HBV-infected pediatric patients 2 years and older are unknown. The long-term effect of lower spine and total body BMD on skeletal growth in pediatric patients 2 years and older, and in particular, the effects of long-duration exposure in younger children is unknown. - Information on dosing, adverse reactions, and clinical trials. - New indication.

治疗类别

Antivirals

立法类型

PREA + BPCA

产品说明书链接

书号

1.0

研究年龄

2 YEARS - 11 YEARS

学习类型

Efficacy,Safety,Tolerability

研究设计

Multicenter,Randomized,Double-Blind,Placebo Control

登记的患者

90

患者分析

89

中心的数量

24

国家数量

6

西班牙裔拉美裔/拉丁裔总计

0

非西班牙裔/非拉丁裔总人数

89

总数#种族不明

0

亚裔学生总数

58

黑人总数

5

白人总数

26

夏威夷或太平洋岛民总数

0

美洲印第安人/阿拉斯加本地人总数

0

其他种族总计

0

未知种族总数

N/A

国家

N/A