EUCTR2018-003474-27-DE进行中（未招募）1 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 - HepNet Acute HCV-V study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •1.Willing and able to provide written informed consent
- •2.Male or female, age > 18 years
- •3.HCV RNA > 103 IU/mL at screening
- •4.Confirmation of acute HCV infection documented by either:
- •a.Documented seroconversion to HCV antibody (anti-HCV) positivity within the 4 months preceding screening
- •b.Documented conversion to HCV RNA positivity within the 4 months preceding screening
- •c.or known or suspected exposure to HCV within the 4 months preceding screening with 10 times elevated serum ALT level at screening or 4 months preceding screening without evidence of confounding liver disorders
- •5.Body mass index (BMI) >18 kg/m2
- •6.Subjects must have the following laboratory parameters at screening:
- •a.INR < 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
- •b.HbA1c <10%
- •c.Creatinine clearance (CLcr) > 30 mL/min, as calculated by the Cockcroft-Gault equation (using actual body weight)
- •7.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 FU:
- •intrauterine device (IUD) with a failure rate of < 1% per year
- •tubal sterilization
- •vasectomy in male partner
- •hormone-containing contraceptive:
- •- implants of progestogen-only hormonal contraception associated with inhibition of ovulation
- •- injectable progestogen-only hormonal contraception associated with inhibition of ovulation
- •- oral contraceptives (either combined or progestogen-only hormonal contraception associated with inhibition of ovulation)
- •- contraceptive vaginal ring
- •- transdermal contraceptive patch
- •8. Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Subject has been treated with any investigational drug or device within 42 days of the Screening visit or within 5 half-lives for investigational drugs, whichever is longer
- •2.Co-Infection with HIV
- •3.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.
- •4.Solid organ transplantation
- •5.Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
- •6.Clinical signs of hepatic decompensation (i.e., clinical ascites, encephalopathy or variceal hemorrhage).
- •7.Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
- •8.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.
- •9.Significant drug allergy (such as anaphylaxis or hepatotoxicity).
- •10.Pregnant or nursing female
- •11.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.
- •12.Clinical relevant(not controlled) liver disease of a non-HCV etiology (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, Wilson’s disease, alpha1 antitrypsin deficiency, cholangitis)
- •13.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
- •14.Known hypersensitivity to SOF/VEL or formulation excipients.
研究者
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