EUCTR2012-003387-43-FR进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Naïve Subjects with Chronic Genotype 1 HCV Infection
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 865
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) HCV treatment-naïve
- •6) HCV genotype 1a, 1b, or mixed 1a/1b at Screening.
- •7) Confirmation of chronic HCV infection
- •8) Cirrhosis determination [up to 20% of study subjects may have
- •9) Liver imaging within 6 months of Baseline/Day 1 to exclude
- •hepatocellular carcinoma (HCC) is required in patients with cirrhosis
- •10) Screening ECG without clinically significant abnormalities
- •11) Laboratory parameters at screening
- •12) Subject has not been treated with any investigational drug or device within 30 days of the Screening visit.
- •13) Specific conditions for female patients in order to be sure they do not become pregnant
- •14) All male study participants must agree to consistently and correctly use a condom while their female partner agrees to use 1 highly effective method of birth control from the date of screening until 7 months after their last dose of RBV or 90 days after their last dose of study drug if not taking RBV.
- •15) Male subjects must agree to refrain from sperm donation from the date of screening until at least 7 months after the last dose of RBV or 90 days after their last dose of study drug if not taking RBV.
- •16) Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator.
- •17) 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 720
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
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;
- •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;
- •h) Malignancy diagnosed or treated within 5 years;
- •i) Significant drug allergy (such as anaphylaxis or hepatotoxicity).
- •2) Pregnant or nursing female or male with pregnant female partner.
- •3) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alpha-1 antitrypsin deficiency, cholangitis).
- •4) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
- •5) Donation or loss of more than 400 mL blood within 2 months prior to Baseline/Day 1
- •6) Clinically-relevant drug abuse within 12 months of screening.
- •7) Alcohol misuse as defined by a Alcohol Use Disorders Identification Test (AUDIT) score = 8
- •8) Contraindications to RBV therapy, including significant history of clinically significant hemoglobinopathy (e.g., sickle cell disease, thalassemia).
- •9) Use of any prohibited concomitant medications within 21 days of the Baseline/Day 1 visit.
- •10) Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day).
- •11) Known hypersensitivity to RBV, GS-5885, sofosbuvir, or formulation recipients.
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