A Multicenter, Open-label Study of Harvoni ® (Sofosbuvir Ledipasvir Fixed Dose Combination) in Subjects Infected With Chronic Hepatitis C and Advanced Heart Failure or Lung Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Number of Subjects Who Completed 24 Weeks of Therapy
研究概览
简要总结
This is a multicenter study in Hepatitis C Virus (HCV) infected adult patients who also have advanced cardiac disease or advanced lung disease.
详细描述
This is a multicenter study in HCV infected adult patients who also have either advanced cardiac disease, or advanced lung disease. Advanced cardiac disease is defined as a marked limitation of physical activity, or discomfort upon physical activity. The patients in the advanced cardiac disease group must also have been hospitalized for heart failure within the last 12 months.
Advanced lung disease is defined as patients who have been diagnosed with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD). Patients in the COPD group must have abnormalities in their forced expiratory volume (FEV) test, which measures the amount of air exhaled. They may or may not need supplemental oxygen. Patients in the ILD group must have been diagnosed with ILD and require supplement oxygen at all times.
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
- •Chronic HCV Infection of Genotype 1, 4, 5, or 6
- •HCV RNA > 103 IU/mL at screening
- •18 years of age or older
- •Diagnosis of chronic HCV infection, defined as positive HCV antibody or HCV RNA more than 6 months prior to screening OR an assessment of fibrosis F2 or greater prior to screening.
- •Subjects in the advanced heart failure cohort must meet all HCV criteria, and all of the following criteria:
- •New York Heart Association (NYHA) Class III or IV functional classification
- •NYHA Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.
- •NYHA Class IV: Patient with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
- •ejection fraction ≤ 30%
- •hospitalized for heart failure in last 12 months
- •Subjects in the advanced lung disease cohort must have been diagnosed with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) must meet all HCV criteria, and meet the following criteria for COPD or ILD:
- •ILD criteria: diagnosis of interstitial lung disease with chronic supplemental oxygen requirement at rest and/or with exertion.
- •COPD criteria (one of the following):
- •Forced expiratory volume (FEV1)< 30% predicted
- •OR any FEV1 with chronic supplemental oxygen requirement at rest and/or with exertion
- •OR any FEV1 with chronic hypercapnia (baseline partial pressure of arterial carbon dioxide [PaCO2] > 45)
排除标准
- •Chronic HCV Infection with Genotype 2 or 3
- •Treatment with any of the following agents
- •Amiodarone. Subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 of SOF/LDV FDC
- •Carbamazepine, phenytoin, phenobarbital, oxcarbazepine
- •Rifabutin, rifampin or rifapentine
- •HIV regimens containing tenofovir or tipranavir/ritonavir
- •St. John's wort
- •Rosuvastatin
- •Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
- •History of hepatic encephalopathy or variceal hemorrhage
- •Hepatitis B surface antigen positive
- •Abnormal hematological and biochemical parameters, including:
- •Hemoglobin (Hb) < 8 g/dL
- •Platelets ≤ 50,000/mm3
- •alanine aminotransferase (ALT), aspartase aminotransferase (AST), or alkaline phosphatase ≥ 10 times upper limit of normal(ULN)
- •Total bilirubin > 3 mg/dl
- •Severe renal impairment creatinine clearance (CrCl), i.e. < 30 mL/min.
- •History of major organ transplantation with an existing functional graft.
- •History of clinically-significant drug allergy to nucleoside/nucleotide analogs.
- •Pregnant women or women planning to become pregnant
- •Women who are breastfeeding
- •Active or recent history (≤ 1 year) of drug or alcohol abuse
研究组 & 干预措施
Heart Failure Cohort
Harvoni (sofosbuvir/ledipasvir fixed dose combination)
1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV)
干预措施: Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC) (Drug)
Lung Disease Cohort
Harvoni (sofosbuvir/ledipasvir fixed dose combination)
1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir
干预措施: Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC) (Drug)
结局指标
主要结局
Number of Subjects Who Completed 24 Weeks of Therapy
时间窗: 24 weeks
The primary safety endpoint is the number of subjects who complete a full course of therapy.
次要结局
- Number of Subjects With Sustained Virologic Response (SVR) 4(4 weeks after completing treatment)
- Number of Subjects With Sustained Virologic Response (SVR) 12(12 weeks after completing treatment)