通用名称

glecaprevir/pibrentasvir

儿科标签批准日期

2019/4/30 0:00:00

特定指示/秒

Chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)

标签更改摘要

- Expanded the indication to adolescents 12 years and older or weighing at least 45 kilograms (kg); previously approved in adults. - Safety, efficacy, and pharmacokinetics in HCV GT1, 2, 3, or 4 infected pediatric patients 12 years and older or weighing at least 45 kg is based on data from an open-label trial in 47 subjects without cirrhosis aged 12-18 years who were either treatment naïve (n=36) or treatment experienced (n=11) and received Mavyret for 8 or 16 weeks. - The safety and efficacy results observed in this trial were consistent with those observed in clinical studies of Mavyret in adults. - In pediatric patients with cirrhosis, history of a kidney and/or liver transplant, or HCV GT5 or 6 infection, the safety and efficacy of Mavyret are supported by the comparable glecaprevir and pibrentasvir exposures observed between adolescents and adults. - Safety and effectiveness in children less than 12 years of age have not been studied. - Information on dosing, adverse reactions, PK parameters, and clinical trials. - Postmarketing study

治疗类别

Antivirals

立法类型

PREA + BPCA

产品说明书链接

书号

2.0 1.0

研究年龄

3 YEARS - 11 YEARS 12 YEARS - 17 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic Efficacy,Safety,Pharmacokinetic

研究设计

Multicenter,Open-Label,Phase 2,Single Arm,3 Multicenter,Open-Label,Phase 2,Single Arm,3

登记的患者

N/A 48

患者分析

N/A 47

中心的数量

N/A N/A

国家数量

N/A 8

西班牙裔拉美裔/拉丁裔总计

N/A 5

非西班牙裔/非拉丁裔总人数

N/A 42

总数#种族不明

N/A 0

亚裔学生总数

N/A 6

黑人总数

N/A 4

白人总数

N/A 35

夏威夷或太平洋岛民总数

N/A 0

美洲印第安人/阿拉斯加本地人总数

N/A 0

其他种族总计

N/A 2

未知种族总数

N/A N/A

国家

N/A N/A