EUCTR2015-003562-90-FR进行中（未招募）1 期
A phase IV open-label, multicentre, international trial of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin for people with chronic hepatitis C virus genotype 1 infection and recent injection drug use or receiving opioid substitution therapy - D3FEAT
The Kirby Institute - UNSW Australia0 个研究点目标入组 100 人开始时间: 2016年7月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
入选标准
- •1.18 years of age or older.
- •2.Detectable HCV RNA in plasma (>1,000 IU/ml).
- •3.Evidence of positive HCV antibody >6 months prior to screening.
- •4.HCV genotype 1 infection.
- •5.Recent injecting drug use (previous 6 months) or receiving opioid substitution therapy.
- •6.Participant has never received treatment for hepatitis C virus infection.
- •7.Compensated liver disease. Enrolment of patients with cirrhosis (FibroScan >14.6 kPa or FIB-4 > 3.25) will be capped to 60% of the total enrolment (maximum 3 per site).
- •8.Participants with FibroScan > 12KPa or AFP >50 ng/mL must have an abdominal ultrasound or CT scan without evidence of hepatocellular carcinoma within 2 months prior to screening.
- •9.Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug.
- •10.All fertile males and females must be using effective contraception during treatment and during 7 months after treatment end (patients treated with ribavirin) or during 30 days after treatment end (patients not treated with ribavirin).
- •11.Participants have voluntarily signed the informed consent form.
- •12.Participants to be covered by medical insurance.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug.
- •2.Any investigational drug ?6 weeks prior to the first dose of study drug.
- •3.HIV infection.
- •4.History or other evidence of decompensated liver disease.
- •5.Neutrophil count <1000 cells/mm3 or platelet count <50,000 cells/mm3 at screening.
- •6.Serum creatinine level >1.5 x upper limit of normal at screening.
- •7.Ongoing severe psychiatric disease as judged by the treating physician.
- •8.Frequent injecting drug use that is judged by the treating physician to compromise treatment safety.
- •9.Inability or unwillingness to provide informed consent or abide by the requirements of the study.
- •10.Haemoglobin <12 g/dL (<7.4 mmol/L) in women or <13 g/dL (<8.1 mmol/L) in men at screening.
- •11.Any exclusion criteria specific to paritaprevir/ritonavir/ombitasvir, dasabuvir or ribavirin.
- •12.Pregnancy/lactation or male subjects whose female partners are pregnant.
- •13.Subject has current or past clinical evidence of decompensated liver disease, such as ascites, hepatic encephalopathy, oesophageal varices, and/or any of the following screening laboratory results;
- •a.International Normalized Ration (INR) >1.5;
- •i.Patients with a known inherited blood disorder and INR > 1.5 may be enrolled after discussion with the Principal Investigator
- •b.Serum albumin <3.3 g/dL;
- •c.Serum total bilirubin >1.8 x upper limit of normal (ULN), unless isolated in subjects with Gilbert’s syndrome.
- •14.Subject shows evidence of significant liver disease in addition to hepatitis C, which may include but is not limited to drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson’s disease, non-alcoholic steatohepatitis (NASH), or primary biliary cirrhosis.
- •15.Subject has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
- •16.History of chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
- •17.Poorly controlled diabetes mellitus as evidenced by haemoglobin A1c (HbA1c) =8.5%.
- •18.Positive test at screening for anti-HAV IgM Ab, anti-HBc IgM Ab or HBsAg.
- •19.Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to screening or on an ultrasound performed at screening (a positive ultrasound result will be confirmed with CT scan or MRI).
- •20.Subject has history of organ transplant that requires chronic immunosuppression (corneal, skin and hair grafts allowed).
- •21.History of severe psychiatric disease that in the opinion of the investigator is unstable enough to compromise treatment adherence.
- •22.Prohibited medications and herbal reme
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