NCT02336139已完成2 期
A Phase II, Open-label, Single Arm, Multicentre, International Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Sustained Virological Response (SVR12)
研究概览
简要总结
To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following sofosbuvir/GS-5816 therapy for 12 weeks in people with chronic HCV infection and recent injection drug use.
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
- •Participants have voluntarily signed the informed consent form.
- •18 years of age or older.
- •Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
- •HCV RNA plasma ≥ 1000 IU/ml at Screening.
- •HCV genotypes 1-
- •Recent injecting drug use (previous 6 months).
- •Compensated liver disease.
- •Participants with Fibroscan >12 KPa or AFP >50 ng/mL must have an abdominal ultrasound or CT scan without evidence of hepatocellular carcinoma within 2 months prior to screening.
- •Negative pregnancy test at baseline (females of childbearing potential only).
- •All fertile males and females must be using effective contraception during treatment and during the 30 days after treatment end.
排除标准
- •History of any of the following:
- •Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
- •Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage)
- •Solid organ transplant
- •Malignancy within 5 years prior to screening, with exception of specific cancers that may have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are also excluded.
- •Significant drug allergy (such as anaphylaxis or hepatotoxicity).
- •Screening ECG with clinically significant abnormalities
- •Any of the following lab parameters at screening:
- •ALT > 10 x ULN
- •AST > 10 x ULN
- •Direct bilirubin > 1.5 x ULN
- •Platelets < 50,0000/μL
- •HbA1c > 8.5%
- •Creatinine clearance (CLcr) < 60 mL/min
- •Haemoglobin < 11 g/dL for females ; < 12 g/dL for males
- •Albumin < 30g/L
- •INR > 1.5 ULN unless subject has known haemophilia or is stable on an anticoagulant regimen affecting INR
- •Pregnant or nursing female.
- •HIV infection or HBV infection (HBcAb and HBsAg positive)
- •Use of prohibited concomitant medications as described in section 5.2
- •Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day)
- •Known hypersensitivity to GS-5816, sofosbuvir (SOF) or formulation excipients.
- •Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months prior to the first dose of study drug.
- •Any investigational drug ≤6 weeks prior to the first dose of study drug.
- •Previous therapy with sofosbuvir (SOF) or an NS5A inhibitor prior to the first dose of study drug.
- •Ongoing severe psychiatric disease as judged by the treating physician.
- •Frequent injecting drug use that is judged by the treating physician to compromise treatment safety.
- •Inability or unwillingness to provide informed consent or abide by the requirements of the study.
研究组 & 干预措施
Sofosbuvir (SOF)/GS-5816
Experimental
12 weeks of Sofosbuvir (SOF)/GS-5816 (400mg/100mg) in an oral once-daily fixed dose combination
干预措施: Sofosbuvir (SOF)/GS-5816 (Drug)
结局指标
主要结局
Sustained Virological Response (SVR12)
时间窗: Week 24
To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following sofosbuvir (SOF)/GS-5816 therapy for 12 weeks in people with chronic HCV infection and recent injection drug use.
次要结局
- Factors associated with on-treatment adherence(Baseline to Week 12)
- Safety and tolerability (number and type of adverse events and serious adverse events)(Baseline to Week 24)
- Change in drug use(Baseline to Week 12)
- Impact of mixed infection on treatment response(Baseline to Week 24)
- Utility of Dried Blood Spot (DBS) (method for monitoring HCV including treatment response)(Week 108)
- Treatment adherence(Baseline to Week 12)
- Impact of adherence on therapy (association between adherence and response to treatment )(early (0-3 weeks), mid (4-7 weeks) and late (8-11 weeks) during therapy)
- End of Treatment Response (ETR) (proportion of participants with undetectable HCV RNA at the end of treatment (ETR)(Week 12)
- Reinfection Rate(Week 108)
- Immunovirological factors associated with treatment clearance(Week 24)
- Change in mental health(Basleine to Week 12)
- Change in health related quality of life(Baseline to Week 12)
研究者
研究点 (1)
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