EUCTR2011-000456-42-HU进行中（未招募）不适用
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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, aged from 18 to 70 years old
- •3. Chronic HCV infection
- •5. Monoinfection with HCV GT 1
- •6. HCV RNA > 10e4 IU/mL
- •7. HCV treatment naïve
- •8. Candidate for PEG/RBV therapy.
- •9. Body mass index (BMI) between 18 and 36 kg/m2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Pregnant female or male with pregnant female partner
- •2. Poorly-controlled diabetes mellitus
- •3. History of clinically significant hemoglobinopathy
- •4. History of clinically significant retinal disease
- •5. History of invasive malignancy diagnosed or treated within 5 years
- •6. Untreated or significant psychiatric illnesses
- •7. Contraindications for PEG or RBV therapy
- •8. Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •9. Chronic use of systemically administered immunosuppressive agents
- •10. Presence of autoimmune disorders
- •11. Severe chronic obstructive pulmonary disease
- •12. History of significant cardiac disease
- •13. Known cirrhosis
- •14. Chronic liver disease of a non-HCV etiology
- •15. History of solid organ transplantation
- •16. Suspicion of hepatocellular carcinoma
- •17. Current or prior history of clinical hepatic decompensation
研究者
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