NCT02759861已完成4 期
A Phase IV, Single Arm, Open-Label Study to Determine the Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF) in Treatment-Naive Alcoholic Subjects With Chronic Genotype 1 Hepatitis C Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The Number of Subjects Who Achieve Negative RNA in Alcoholics
研究概览
简要总结
To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection
详细描述
determine the cure rate of Harvoni in treatment naïve alcoholic subjects with Genotype 1 HCV infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be willingly and able to provide written informed consent
- •Age 19 years of age or older (The age of consent in Nebraska)
- •HCV treatment-naïve, as defined as no prior exposure to any Interferon (IFN), RBV, or other FDA approved or experimental HCV-specific direct-acting antiviral agent
- •HCV RNA level at most 6 months prior to the Baseline/Day 1 visit.
- •HCV genotyping 1a, 1b, or mixed 1a/ab. Any non-definitive results will exclude the subject from study participation.
- •Alcohol misuse as defined by the Alcohol Use Disorders Identification Test (AUDIT) score subjects must score > 8 (associated with harmful or hazardous drinking)
- •Cirrhosis determination [up to 20% of study subjects may have cirrhosis]:
- •Cirrhosis is defined as any one of the following:
- •History of a liver biopsy showing cirrhosis (e.g. Metavir score = 4 or Ishak score > 5)
- •Fibroscan showing cirrhosis or results > 12.5 kPa
- •FIBRO Spect II index consistent with F3 or F4 AND an AST : platelet ration index (APRI) of > 2 during Screening
- •Absence of cirrhosis is defined as any one of the following:
- •Liver biopsy within 2 years of Screening showing absence of cirrhosis
- •Fibroscan within 6 months of Baseline/Day1 with a result of ≤ 12.5 kPa
- •FIBRO Spect II Index consistent with F0- F2 AND APRI of ≤ 1 during Screening
- •Liver imaging within 6 months of Baseline/Day 1 to exclude hepatocellular carcinoma HCC) is required
- •Subjects must have the following laboratory parameters at screening:
- •ALT < 10 x the upper limit of normal (ULN)
- •AST < 10 x ULN
- •Direct bilirubin < 2.0 x ULN
- •Platelets > 50,000
- •HbA1c < 8.5%
- •Creatinine clearance (CLcr) ≥ 60 mL /min, as calculated by the Cockcroft-Gault equation
- •Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects.
- •Albumin ≥ 2.5 g/dL
- •INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
- •Subject has not been treated with any investigational drug or device within 30 days of the screening visit.
排除标准
- •Pregnant women and nursing mothers are ineligible due to the possible risk of adverse effects in the newborn. Eligible patients of reproductive potential should use adequate contraception if sexually active.
- •Serious concurrent medical illness which would jeopardize the ability of the subject to receive the therapy as outlined in this protocol with reasonable safety.
- •Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for a malignancy are not eligible.
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •Use of any prohibited concomitant medications within 30 days of the Baseline/Day 1 visit.
- •Known hypersensitivity to LDV/SOF
研究组 & 干预措施
Harvoni x 8 or 12 weeks
Experimental
patient will receive 8 or 12 weeks depending on clinical data
干预措施: harvoni (Drug)
结局指标
主要结局
The Number of Subjects Who Achieve Negative RNA in Alcoholics
时间窗: 12 weeks after the end of Harvoni therapy
Sustained viral response in treatment -naive heavy alcohol drinking patients.
次要结局
- Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR(12 weeks after the end of Harvoni therapy)
研究者
研究点 (1)
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