EUCTR2012-000571-16-SE进行中（未招募）不适用
An Open-Label Study of GS-7977 + Ribavirin with or without PeginterferonAlfa-2a in Subjects with Chronic HCV Infection who Participated in PriorGilead HCV Studies.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- 性别
- All
入选标准
- •1. Willing and able to provide written informed consent
- •2. Chronic HCV
- •3. Subject must have participated in a prior Gilead HCV study
- •4. HCV RNA >LLOQ
- •5. Screening ECG without clinically significant abnormalities
- •6. Subjects must have a number of laboratory parameters within defined ranges at screening
- •7. A female subject is eligible to enter the study if it is confirmed that she is:
- •a) Not pregnant or nursing
- •b) Of non-childbearing potential
- •c) Of childbearing potential but with a negative serum pregnancy test at screening and a negative urine pregnancy test on the Baseline/Day 1 visit prior to randomization and agree to one of the described forms of contraception during the course of the study and up to 7 months following cessation of Ribavirin therapy.
- •8. All male study participants must agree to consistently and correctly use a condom while their female partner agrees to use 1 of the methods of birth control listed in the protocol from the date of screening until 7 months after their last dose of RBV.
- •9. Male subjects must agree to refrain from sperm donation for at least 7 months after the last dose of RBV.
- •10. Subject must be of generally good health as determined by the Investigator.
- •11. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
- •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 540
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Pregnant or nursing female or male with pregnant female partner
- •2. Current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage).
- •3. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •4. Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day)
- •5. Active substance abuse which, in the opinion of the investigator, would make the candidate inappropriate for participation in this study.
- •6. Use of any prohibited concomitant medications as described in Section 5.6 within 28 days of the Baseline/Day 1 visit
研究者
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