EUCTR2020-005777-27-DE进行中（未招募）1 期
A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents with Acute Hepatitis C Virus (HCV) Infection
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 283
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
- •- Adult or adolescent, age 12 years and older
- •- Subject must have evidence of acute HCV infection prior to enrollment. Evidence of acute HCV infection is defined as physician diagnosis of
- •acute HCV infection and at least 1 of the following:
- •- Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to Screening OR Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to Screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen OR Clinical signs and symptoms compatible with acute hepatitis (ALT > 5 × ULN and/or jaundice) in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to Screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen OR Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to Screening.
- •- Subject must be HCV treatment-naïve, defined as no prior treatment including interferon for this HCV infection.
- •- Subject must be documented as either having no cirrhosis or as having compensated cirrhosis.
- •- Absence of hepatocellular carcinoma (HCC) for subjects with cirrhosis as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative ultrasound at Screening. Subject who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study.
- •- No history of liver decompensation
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 253
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •- Evidence of chronic HCV infection for this HCV infection.
- •- Subject has a history of severe life-threatening or other significant sensitivity to any excipients of the study drug.
- •- Subject has cause of liver disease other than HCV infection
- •- Subject has uncontrolled drug use that may impair protocol compliance in the
- •opinion of the investigator.
- •- Female who is pregnant or breastfeeding; or is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug.
- •- Subject must require chronic use of systemic immunosuppressants during the study
研究者
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已完成
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