NCT02480387已完成2 期
A Phase 2, Single-Center, Open-Label Pilot Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
Peter J. Ruane, M.D., Inc.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- SVR12
研究概览
简要总结
Target Population: Hepatitis C Treatment Naïve, non-cirrhotic, Chronic genotype 1 hepatitis C virus (HCV) infected adults that are co-infected with human immunodeficiency virus (HIV)-1and have HCV RNA < 6 x106 IU/mL
Duration of Subjects will be treated for 8 weeks and followed for 24 weeks post- Treatment: treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •Chronic HCV GT1, treatment-naïve, non-cirrhotic adult subjects.
- •HCV RNA levels more than 10,000 IU/mL and less than 6,000,000 IU/mL at Screening
排除标准
- •Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
- •Solid organ transplantation.
- •Significant cardiac disease or other significant co-morbidities that could interfere with study treatment.
- •Malignancy within the 3 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible.
- •Infection with hepatitis B virus (HBV)
研究组 & 干预措施
Treatment Arm
Experimental
8 weeks treatment with Ledipasvir/Sofosbuvir FDC
干预措施: Ledipasvir/Sofosbuvir FDC (Drug)
结局指标
主要结局
SVR12
时间窗: Sustained Virologic Response 12 Weeks Post-Treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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