EUCTR2015-003460-36-DE进行中（未招募）1 期
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects with Chronic HCV Infection
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 943
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) Body mass index (BMI) = 18 kg/m2
- •4) HCV RNA = 104 IU/mL at Screening
- •5) Chronic HCV infection (= 6 months) documented by prior medical history or liver biopsy.
- •6) HCV treatment status of one of the following:
- •a) Treatment-naïve with no prior exposure to any IFN, RBV, or approved or experimental HCV-specific DAA
- •b) Treatment experienced with an IFN-based regimen and no prior exposure to an approved or experimental HCV-specific DAA
- •c) The subject’s medical records must include sufficient detail of prior treatment(s) to confirm eligibility
- •7) Cirrhosis Determination a) Presence of cirrhosis is defined as in the protocol b) Absence of cirrhosis is defined as in the protocol
- •8) Liver imaging within 6 months prior to Day 1 is required in cirrhotic subjects to exclude hepatocellular carcinoma (HCC)
- •9) Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to enrollment
- •10) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- •11) Lactating females must agree to discontinue nursing before starting study drug.
- •12) Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator
- •13) Subject must be able to comply with the dosing instructions for study drug administration and 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 849
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 94
排除标准
- •1) Current or prior history of any of the following:
- •a. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded
- •b. Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
- •c. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
- •d. Hepatic decompensation (e.g., clinical ascites, encephalopathy, and/or variceal hemorrhage)
- •e. Solid organ transplantation
- •f. Significant cardiac disease
- •g. Unstable psychiatric condition including hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within 2 years prior to Screening
- •h. Malignancy within the 5 years prior to Screening, with the exception of specific cancers that have been cured by surgical resection.
- •i. Significant drug allergy (e.g., hepatotoxicity)
- •2) Screening ECG with clinically significant abnormalities
- •4) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis)
- •5) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •6) Clinically-relevant alcohol or drug abuse within 12 months of Screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator
- •7) Use of any prohibited concomitant medications
- •8) Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
研究者
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