NCT01743521已完成4 期
Direct Acting Antiviral (DAA) Based Therapy for Recently Acquired Hepatitis C
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment)
研究概览
简要总结
To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin, Telaprevir) for the treatment of early chronic Hepatitis C Virus (HCV) infection.
详细描述
DARE-C is a prospective open label multi-centre pilot study examining the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin and Telaprevir) for the treatment of early chronic HCV genotype 1 infection in individuals with and without HIV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written, informed consent.
- •HCV genotype 1 infection
- •Quantifiable HCV RNA at screening and baseline (>10,000 IU/ml)
- •Recent hepatitis C infection with an estimated duration of Infection >6 months and ≤ 18 months defined as A) i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV antibody negative or HCV RNA negative within the 24 months prior to anti-HCV antibody positive result OR B) i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the 12 months prior to first positive HCV antibody or HCV RNA with no other cause of acute hepatitis identifiable
- •Compensated liver disease (Child-Pugh A)
- •Negative pregnancy test at screening and 24 hours prior to the first dose of study drugs.
- •If heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives from screening onwards until 6 months (female subject) or 7 months (male subject) after RBV therapy has ended. Note: Hormonal contraceptives may be continued but may not be reliable during telaprevir dosing and for 2 months following cessation of telaprevir. Therefore, subjects should agree to use 2 effective non-hormonal methods of contraception during telaprevir combination therapy and for 2 months after the last intake of telaprevir. As of two months after completion of telaprevir hormonal contraceptives can again be used as one of the two required effective methods of birth control.
- •Subject is judged to be medically stable on the basis of physical examination, medical history and vital signs.
- •Adequate English to provide written, informed consent and to provide reliable responses to the study interview
- •Additional inclusion criteria for HIV positive individuals
- •Confirmed HIV infection > 6 months duration
- •CD4 > 200 cells/mm3 and HIV < 50 c/ml on stable antiretroviral therapy (ART) at least 3 months prior to treatment
- •CD4 >= 500 cells/mm3 and HIV viral load (VL) < 100,000 not on ART
- •If on ART must be taking a regimen containing an accepted* combination of the following drugs: tenofovir ( TDF), lamivudine ( 3TC), emtricitabine (FTC), efavirenz (EFV), abacavir (ABC), raltegravir (RAL), etravirine (ETV), rilpivirine (RIL), ritonavir boosted atazanavir (r/ATZ) * Combination must be supported by current HIV treatment guidelines
排除标准
- •Individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples
- •Current injecting drug use (any injecting within previous 4 weeks)
- •Standard exclusions to Pegylated-interferon (PEG-IFN), Ribavirin (RBV) and Telaprevir (TPV) therapy
研究组 & 干预措施
Group A - 8 weeks total therapy
Experimental
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
干预措施: TPV/PEG-IFN/RBV (Drug)
Group B - 12 weeks total therapy
Experimental
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
干预措施: TPV/PEG-IFN/RBV (Drug)
Group C - 24 weeks total therapy
Experimental
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
干预措施: TPV/PEG-IFN/RBV (Drug)
结局指标
主要结局
SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment)
时间窗: 12 weeks post-treatment
Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion)
次要结局
- SVR24(24 weeks post-treatment)
- Undetectable HCV RNA (ETR)(Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C))
- Undetectable HCV RNA (Week 1)(Week 1 of therapy)
- Undectectable HCV RNA (Week 2)(Week 2 of therapy)
- Undetectable HCV RNA (Week 3)(Week 3 of therapy)
- Undetectable HCV RNA (Week 4)(Week 4 of therapy)
- Decrease in Absolute Neutrophil Count (ANC) ≤0.75(Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C))
- Decrease in Platelets <50(Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C))
- Change in Hemoglobin at End of Treatment(Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C))
- Resistance-associated Variants(Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C))
- Baseline Resistance-associated Variants(Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C))
- Plasma Ribavirin Levels(Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C))
- CD4 and HIV RNA(Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C))
- Gene IL28B Polymorphism(Baseline)
研究者
研究点 (2)
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