EUCTR2014-001683-35-GB进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety ofSofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects with Chronic HCV - ASTRAL 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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 greater than or equal to 18 years
- •3) HCV RNA greater than or equal to 100,000 IU/mL at Screening
- •4) HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at Screening by the Central Laboratory.
- •5) Chronic HCV infection (= 6 months) documented by prior medical history or liver biopsy
- •6) Classification as treatment naïve or treatment experienced:
- •a) Treatment naïve is defined as having never been exposed to approved or experimental HCV-specific direct-acting antiviral agents or prior treatment of HCV with interferon or ribavirin
- •b) Treatment experienced is defined as prior treatment failure to a regimen containing interferon either with or without RBV that was completed at least 8 weeks prior to Baseline/Day 1. Subject must not have discontinued the prior regimen that resulted in virologic failure due to an adverse event.
- •i) The subject’s medical records must include sufficient detail of prior virologic failure to allow for categorization of prior response, as either:
- •(1) Non-Responder: Subject did not achieve undetectable HCV RNA levels while on treatment, or
- •(2) Relapse/Breakthrough: Subject achieved undetectable HCV RNA levels during treatment or within 4 weeks of the end of treatment but did not achieve SVR
- •7) Cirrhosis Determination (approximately 20% of subjects may have cirrhosis)
- •a) Cirrhosis is defined as any one of the following
- •i) Liver biopsy showing cirrhosis (e.g., Metavir score = 4 or Ishak score =5)
- •ii) FibroTest® score > 0.75 AND an AST:platelet ratio index (APRI) > 2 during Screening
- •iii) Fibroscan with a result of >12.5 kPa
- •b) Absence of cirrhosis is defined as any one of the following:
- •i) Liver biopsy within 2 years of Screening showing absence of cirrhosis
- •ii) FibroTest® score = 0.48 AND APRI = 1 performed during Screening
- •iii) Fibroscan with a result of = 12.5 kPa within = 6 months of Baseline/Day 1
- •In the absence of a definitive diagnosis of presence or absence of cirrhosis by Fibrotest® /APRI using the above criteria, a liver biopsy or fibroscan is required. Liver biopsy results will supersede Fibrotest® /APRI or fibroscan results and be considered definitive.
- •8) Liver imaging within 6 months of Baseline/Day 1 is required in cirrhotic patients only 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 Baseline/Day 1 prior to randomization.
- •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 the study drug is administered
- •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 540
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
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) Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
- •e) Solid organ transplantation.
- •f) Significant pulmonary disease, significant cardiac disease or porphyria.
- •g) Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. Subjects with psychiatric illness (without the prior mentioned conditions) that is well-controlled on a stable treatment regimen for at least 12 months prior to randomization or has not required medication in the last
- •12 months may be included.
- •h) Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible.
- •i) Significant drug allergy (such as anaphylaxis or hepatotoxicity).
- •2) Screening ECG with clinically significant abnormalities
- •3) Subjects has the following laboratory parameters at screening:
- •a) ALT > 10 x the upper limit of normal (ULN)
- •b) AST > 10 x ULN
- •c) Direct bilirubin > 1.5 x ULN
- •d) Platelets < 50,000/uL
- •e) HbA1c > 8.5%
- •f) Creatinine clearance (CLcr) < 60 mL /min as calculated by the Cockcroft-Gault equation
- •g) Hemoglobin < 11 g/dL for female subjects; < 12 g/dL for male subjects.
- •h) Albumin < 3 g/dL
- •i) INR > 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
- •4) Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor.
- •5) Pregnant or nursing female or male with pregnant female partner.
- •6) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis).
- •7) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
- •8) 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.
- •9) Use of any prohibited concomitant medications
- •10) Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day).
- •11) Known hypersensitivity to GS-5816, SOF, or formulation excipients.
- •12) History of clinically significant hemoglobinopathy (e.g., sickle cell disease, thalassemia)
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