An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without Ribavirin (RBV) in Pediatric Subjects With Genotype 1 or 4 Chronic Hepatitis C Virus (HCV) Infection (ZIRCON)

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 74 人开始时间: 2015年12月7日最近更新: 2021年4月26日

研究概览

暂无简介。

•1. Male or female =3 to 17 years of age at time of enrollment.
•2. Willingness to participate in the study for up to 50 months.
•3. HCV infection demonstrated by positive anti-HCV Ab and HCV RNA = 1000 IU/mL at the time of screening
•4. Screening laboratory results indicating HCV genotype 1 for enrollment into part 1 and genotype 1 or 4 for enrollment into Part 2.
•5.Parent or legal guardian with the willingness and ability to provide written informed consent and subject willing and able to give assent, as appropriate for age and coutry.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 62
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Women who are pregnant, breastfeeding, or are considering becoming pregnant.
•2. Use of known strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in participants receiving dasabuvir, or strong or moderate inducers of CYP3A, within 2 weeks or 10 half lives, whichever is longer, of the
•respective medication/supplement prior to study drug administration.
•3. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody (HIV Ab) test.
•4. Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than IFNs or RBV or receipt of any investigational product within 6 weeks prior to study drug administration.

发起方