Comparative Efficacy of Fixed-dose Combination of Sofosbuvir and Ledipasvir for 8 or 12 Weeks for Chronic Hepatitis C Genotype 6
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment
研究概览
简要总结
The primary objectives of this study are to describe the efficacy of:
- 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6
- 12-week treatment of SOF/LED for all other HCV-6 populations
详细描述
The secondary objective of this study is to describe safety, persistency, and tolerability of SOF/LED in patients with HCV-6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥18 years
- •HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6
- •Selected to start on treatment by their treating providers
- •Willing and able to provide informed consent
- •Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments
- •Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline
- •Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- •Lactating females must agree to discontinue nursing before the study drug is administered
排除标准
- •Previous recipient of a liver transplant
- •Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)
研究组 & 干预措施
12 weeks SOF/LED
Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
干预措施: 12 weeks SOF/LED (Drug)
8 weeks SOF/LED
Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
干预措施: 8 weeks SOF/LED (Drug)
结局指标
主要结局
Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment
时间窗: 12 weeks after end of therapy
次要结局
- Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.(Day 1 of treatment to 12 weeks post treatment)
研究者
Mindie H. Nguyen
Associate Professor of Medicine
Stanford University