DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral) (DARE-C II)
An Interferon Sparing Strategy of Sofosbuvir Plus Ribavirin for the Treatment of Recently Acquired Hepatitis C Infection
The purpose of the study is to examine whether patients who have acute or early chronic hepatitis C virus (HCV) infection can be treated effectively and safely with an interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this study will investigate whether treatment of acute or early chronic HCV can be shortened. The study will assess efficacy by looking at the proportion of people who clear the virus (have no virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after treatment.
The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will result in successful virological eradication in the majority (≥80%) of subjects treated for recently acquired HCV.
研究概览
详细说明
To evaluate the efficacy, safety and acceptability of an interferon-sparing strategy with sofosbuvir and ribavirin for the treatment of recently acquired HCV infection.
An open label single arm multicentre study Treatment of participants: Sofosbuvir 400mg daily with weight based ribavirin (1000mg <75 kg, 1200mg >/= 75kg) Duration of treatment will be 6 weeks for all subjects followed by 52 weeks of observational follow-up Total study duration = 58 weeks Primary endpoint: SVR 12
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Grafton
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Auckland、Grafton、新西兰、1023
- Auckland City Hospital
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New South Wales
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Sydney、New South Wales、澳大利亚、2010
- St Vincent's Hospital
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South Australia
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Adelaide、South Australia、澳大利亚、5000
- Royal Adelaide Hospital
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Victoria
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Melbourne、Victoria、澳大利亚、3050
- Royal Melbourne Hospital
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Melbourne、Victoria、澳大利亚、3004
- Alfred Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Provision of written informed consent
- Male and female patients aged 18 years and above
- Willing to use two effective methods of contraception during the treatment period and 24 weeks post.
- HBsAg negative
- Detectable HCV RNA at screening (>10,000 IU/ml), and in the opinion of the investigator is unlikely to demonstrate spontaneous viral clearance
- Compensated liver disease (Child-Pugh A)
- Negative pregnancy test at screening and 24 hours prior to first dose of study drugs
- Medically stable on the basis of physical examination, medical history and vital signs
- Adequate English to provide reliable responses to the study questionnaires
- Recent hepatitis C infection, as defined by: A) i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV Ab negative within the 24 months prior to anti-HCV antibody positive result, OR B) i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the previous 12 months prior to first positive HCV antibody or HCV RNA, with no other cause of acute hepatitis identifiable
If co-infection with HIV is documented, the subject must meet the following criteria:
- Antiretroviral (ARV) untreated for >8 weeks preceding screening visit with CD4 T cell count >500 cells/mm3 OR
- On a stable ARV regimen for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and an undetectable plasma HIV RNA level.
Exclusion Criteria:
- Standard exclusions to RBV therapy
- Pregnancy/lactation or male subjects whose female partners are pregnant
- Subject has a history of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding oesophageal varices, and/or any of the following screening laboratory results: a.INR of ≥1.5; Serum albumin <3.3 g/dL; Serum total bilirubin >1.8 times upper limit of normal, unless isolated in subjects with Gilbert's syndrome.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Sofosbuvir and ribavirin
Sofosbuvir tablet 400 mg daily Ribavirin tablet weight based dosing (1000mg <75 kg, 1200mg >/= 75kg) daily Treatment will be for 6 weeks in all participants. |
Sofosbuvir 400mg daily plus weight-based dosing ribavirin (1000mg <75kg, 1200mg >/= 75 kg) Treatment will be for 6 weeks in all participants.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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SVR 12
大体时间：12 weeks post treatment
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Proportion of patients with undetectable HCV RNA by TaqMan 12 weeks after therapy completion (SVR 12 - Week 18)
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12 weeks post treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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SVR 24
大体时间：24 weeks post treatment
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Proportion of patients with undetectable HCV RNA by TaqMan 24 weeks after therapy completion (SVR 24 - Week 30)
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24 weeks post treatment
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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End of treatment response
大体时间：End of treatment week 6
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Proportion of patients with undetectable HCV RNA at end of therapy (ETR - week 6)
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End of treatment week 6
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SVR 4
大体时间：4 weeks post treatment
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Proportion of patients with undetectable HCV RNA by TaqMan 4 weeks after therapy completion (SVR 4 - Week 10)
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4 weeks post treatment
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Follow up 1 year
大体时间：1 year post treatment
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Proportion of patients with undetectable HCV RNA at end of study follow-up (FU1 - Week 58)
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1 year post treatment
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Undetectable HCV RNA
大体时间：Week 1, 2, 3 and 4 of treatment
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Proportion of patients with undetectable HCV RNA at weeks 1, 2, 3 and 4
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Week 1, 2, 3 and 4 of treatment
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Indicators of toxicity (ALT, HB, Neutrophils, Platelets)
大体时间：Baseline until week 4 of treatment
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To evaluate indicators of toxicity (ALT, HB, Neutrophils, Platelets) during therapy
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Baseline until week 4 of treatment
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Plasma ribavirin levels and haemoglobin
大体时间：Baseline to week 4 of treatment
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To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy
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Baseline to week 4 of treatment
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Incidence of reinfection
大体时间：End of treatment until follow up 1 year
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Incidence of reinfection after documented SVR
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End of treatment until follow up 1 year
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合作者和调查者
调查人员
- 首席研究员：Gail Matthews, MbChB FRACP、Kirby Institute
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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