EUCTR2015-000178-36-GB进行中（未招募）1 期
A phase II, open-label, single arm, multicentre, international trial of sofosbuvir and GS-5816 for people with chronic hepatitis C virus infection and recent injection drug use - simplify
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 103
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible to participate in this study.
- •1Participants have voluntarily signed the informed consent form.
- •218 years of age or older.
- •3Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
- •4HCV RNA plasma = 1000 IU/ml at Screening.
- •5HCV genotypes 1-6.
- •6Recent injecting drug use (previous 6 months).
- •7Compensated liver disease. Enrolment of patients with cirrhosis (Fibroscan >14.6 kPa or FIB-4 > 3.25) will be capped to 40% of the total enrolment (maximum 2 per site).
- •8Participants 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.
- •9Negative pregnancy test at baseline (females of childbearing potential only)
- •10All fertile males and females must be using effective contraception during treatment and during the 30 days after treatment end.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Subjects who meet any of the exclusion criteria are not to be enrolled in this study.
- •1History of any of the following:
- •a.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.
- •b.Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage)
- •c.Solid organ transplant
- •d.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.
- •e.Significant drug allergy (such as anaphylaxis or hepatotoxicity).
- •2Screening ECG with clinically significant abnormalities
- •3Any of the following lab parameters at screening:
- •a.ALT > 10 x ULN
- •b.AST > 10 x ULN
- •c.Direct bilirubin > 1.5 x ULN
- •d.Platelets < 50,000/µL
- •e.HbA1c > 8.5%
- •f.Creatinine clearance (CLcr) < 60 mL/min
- •g.Haemoglobin < 11 g/dL for females ; < 12 g/dL for males
- •h.Albumin < 30g/L
- •i.INR > 1.5 ULN unless subject has known haemophilia or is stable on an anticoagulant regimen affecting INR
- •4Pregnant or nursing female.
- •5HIV infection or HBV infection (HBcAb and HBsAg positive)
- •6Use of prohibited concomitant medications as described in section 5.2
- •7Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day)
- •8Known hypersensitivity to GS-5816, SOF or formulation excipients.
- •9Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug.
- •10Any investigational drug =6 weeks prior to the first dose of study drug.
- •11Previous therapy with sofosbuvir or an NS5A inhibitor prior to the first dose of study drug.
- •12Ongoing severe psychiatric disease as judged by the treating physician.
- •13Frequent injecting drug use that is judged by the treating physician to compromise treatment safety.
- •14Inability or unwillingness to provide informed consent or abide by the requirements of the study.
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