NCT03818308已完成2 期
Multicenter Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir Fix Dose combination_The HepNet Acute HCV-V Study
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
- 20
- 试验地点
- 14
- 主要终点
- Proportion of subjects with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy
研究概览
简要总结
This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment with sofosbuvir (SOF)/velpatasvir (VEL) fix dose combination (FDC) in patients with acute hepatitis C virus (HCV) infection.
详细描述
This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment with SOF/VEL FDC for 8 weeks in patients with acute HCV infection as measured by the proportion of subjects with sustained viral response (undetectable HCV RNA) 12 weeks after stop of therapy.
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
- •Willing and able to provide written informed consent
- •Male or female, age > 18 years
- •HCV RNA > 10^3 IU/mL at screening
- •Confirmation of acute HCV infection documented by either:
- •Documented seroconversion to HCV antibody (anti-HCV) positivity within the 4 months preceding screening
- •Documented conversion to HCV RNA positivity within the 4 months preceding screening
- •or known or suspected exposure to HCV within the 4 months preceding screening with 10 times elevated serum ALT level at screening or 4 month preceding screening without evidence of confounding liver disorders
- •Body mass index (BMI) ≥18 kg/m2
- •Subjects must have the following laboratory parameters at screening:
- •INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
- •HbA1c ≤ 10%
- •Creatinine clearance (CLcr) ≥ 30 mL/min, as calculated by the Cockcroft-Gault equation (using actual body weight)
- •A negative serum pregnancy test is required for female subjects (unless surgically sterile or women ≥ 54 years of age with cessation for 24 ≥ months of previously occurring menses). Complete abstinence from intercourse. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.
- •Consistent and correct use of 1 of the following methods of birth control listed below, in addition to a male partner who correctly uses a condom, from the date of Screening until the end of follow up:
- •intrauterine device (IUD) with a failure rate of < 1% per year
- •female barrier method: cervical cap or diaphragm with spermicidal agent
- •tubal sterilization
- •vasectomy in male partner
- •hormone-containing contraceptive:
- •implants of levonorgestrel
- •injectable progesterone
- •oral contraceptives (either combined or progesterone only)
- •contraceptive vaginal ring
- •transdermal contraceptive patch
- •Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments
排除标准
- •Subject has been treated with any investigational drug or device within 42 days of the Screening visit
- •Co-Infection with HIV
- •Clinically-significant illness (other than HCV) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol.
- •Solid organ transplantation
- •Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
- •Clinical signs of hepatic decompensation (i.e., clinical ascites, encephalopathy or variceal hemorrhage).
- •Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
- •Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 2 years. Subjects with psychiatric illness that is well-controlled on a stable treatment regimen for at least 12 months prior to screening or has not required medication in the last 12 months may be included.
- •Significant drug allergy (such as anaphylaxis or hepatotoxicity).
- •Pregnant or nursing female
- •Clinically-relevant drug or alcohol abuse that significantly impairs patient compliance. Uncontrolled users of intravenous drugs will not be permitted to enroll in the study.
- •Clinical relevant (not controlled) liver disease of a non-HCV etiology (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
- •Use of any prohibited concomitant medications within 21 days before the Baseline/Day 1 visit. The use of amiodarone is prohibited from 60 days prior to Day 1 through the end of treatment;
- •Known hypersensitivity to SOF/VEL or formulation excipients
研究组 & 干预措施
Sofosbuvir and Velpatasvir
Experimental
SOF/VEL FDC film-coated tablet, oral, SOF 400 mg/VEL 100 mg daily, 8 weeks
干预措施: Sofosbuvir and Velpatasvir (Drug)
结局指标
主要结局
Proportion of subjects with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy
时间窗: 12 weeks after discontinuation of therapy
Measured by the portion of subjects with sustained virological response (undetectable HCV RNA)
次要结局
- Mean HCV RNA viral load at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after stop of therapy(at baseline, after 2 weeks, 4 weeks and 8 weeks of therapy, and 12 weeks after stop of therapy)
- Assessment of frequency and severity of adverse events (AEs)(through study completion, an average of 20 weeks)
- Proportion of subjects who reached ALT normalization (ALT < ULN) after 8 weeks of therapy and 12 weeks after discontinuation of therapy(after 8 weeks of therapy, and 12 weeks after discontinuation of therapy)
研究者
研究点 (14)
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