EUCTR2011-005393-32-PT进行中（未招募）1 期
An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent DAA) Treatment in Combination with Peginterferon a-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous AbbVie or Abbott DAA Combination Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •To be enrolled in this protocol, subjects must meet all of the following inclusion criteria:
- •1.Subject must have experienced virologic failure as defined in a previous AbbVie/Abbott DAA combination trial.
- •2.Female subjects of childbearing potential must be willing to use two effective forms of birth control (not including oral contraceptives or contraceptives containing ethinyl estradiol or depo-progesterone) while receiving study drug and for 7 months (or per local ribavirin label) after stopping study drug (Note: Hormonal contraceptives, including oral, topical, injectable or implantable varietes, may not be used during DAA treatment). Females are considered of childbearing potential unless they are either:
- •-Post menopausal for at least 2 years prior to screening (defined as amenorrheic for longer than 2 years, age appropriate, and confirmed by a follicle-stimulating hormone [FSH] level indicating a postmenopausal state), or
- •-Surgically sterile (defined as history of bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or has a vasectomized partner(s), or
- •-Practicing total abstinence from sexual intercourse (minimum 1 complete menstrual cycle), or
- •-Sexually active with female partner(s) only.
- •3.Males must be surgically sterile, or have male partners only, or if sexually active with female partner(s) of childbearing potential must agree to practice two effective forms of birth control throughout the course of the study, starting with Study Day 1 and for 7 months (or per local ribavirin label) after the last dose of study drug, unless abstinent from sexual intercourse. (Note: Contraceptives containing ethinyl estradiol or depo-progesterone may be considered effective if used by the female partners of male subjects.)
- •4.For cirrhotic subjects, compensated cirrhosis defined as Child-Pugh score of = 6 at Screening.
- •5.Subject is infected with HCV genotype 1 at Screening Visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •To be enrolled in this protocol, subjects must not meet any of the following exclusion criteria:
- •1.In subjects with a prior null or partial response to pegIFN/RBV treatment at any time prior to pre-screening for this study or any prior failure with pegIFN/RBV plus telaprevir, the presence of variants relative to the appropriate prototypic reference sequence (H77 for 1a or Con1 for 1b) at any of the following amino acid positions: NS3 protease 155, 156, or 168; NS5A 28, 29, 30, 31, 32, 58, or 93.
- •2.Females who are pregnant or plan to become pregnant, or breastfeeding, or males whose partners are pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of RBV.
- •3.Use of known strong inhibitors (e.g., ketoconazole) or inducers (e.g., phenobarbital, rifampin, carbamazepine, St. John's Wort) of CYP3A within 2 weeks prior to study drug administration.
- •4.Use of any medications contraindicated for use with ABT 450, ABT 267, pegIFN, RBV or ritonavir within 2 weeks prior to study drug administration.
- •5.Discontinuation of antiviral therapy due to intolerance or a DAA or RBV associated adverse event in a previous AbbVie/Abbott DAA combination study (excluding intolerance or AEs associated with telaprevir).
研究者
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