A Study to Investigate HCV Response Rates in Real World Patients Traditionally Excluded From Clinical Trials: The HEARTLAND Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- The primary analysis will be sustained virologic response 12 weeks after the last treatment dose (SVR12) for the all treated population.
研究概览
简要总结
This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting.
详细描述
This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting.
The study will enroll chronically infected GT 1 patients who are treatment naïve or who have failed a regimen including pegIFN/RBV +/- telaprevir, boceprevir, or simeprevir.
In addition, up to 20 chronically infected GT1 patients who have traditionally been excluded from clinical trials due to mild to moderate renal insufficiency, irrespective of other co-morbid conditions including poorly controlled diabetes mellitus, high BMI, HIV infection will be enrolled.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients must have chronic GT 1 HCV infection (GT1a, GT1b or GT1a/1b)
- •Patient and partner(s) must agree to use acceptable methods of contraception
- •Patient must be able to read and understand English and/or Spanish
- •Written informed consent
排除标准
- •Currently taking or planning on taking any prohibited medications (see US PI)
- •Evidence of decompensated liver disease (Child-Pugh B or C) including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy
- •Abnormal lab values, including:
- •Hemoglobin (Hgb) <8 g/dL
- •Platelets <25,000 cells/mm3
- •Absolute neutrophil count (ANC)<500 cells/mm3
- •Bilirubin >3
- •INR>2.3 ALT/AST > 10 x ULN
- •Serum albumin <2.8
- •GFR <30 mL
- •Alcohol use: >3 drinks per day consistently
- •Uncontrolled HIV or HBV coinfection
研究组 & 干预措施
Single
Ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + databuvir (DSV) +/- ribavirin (RBV)
干预措施: paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin (Drug)
结局指标
主要结局
The primary analysis will be sustained virologic response 12 weeks after the last treatment dose (SVR12) for the all treated population.
时间窗: 12 weeks after last treatment
Primary Analysis
次要结局
- Evaluate patient reported outcomes via the SF36v2 survey (subgroups: those who achieve SVR12 and those who do not)(12 weeks after last treatment)
- Evaluate patient adherence (subgroups: those who achieve SVR12 and those who do not)(12 weeks after last treatment)
- Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs)(12 weeks after last treatment)