Randomized Clinical Trial to Assess the Effectiveness of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1 (TNT-1 Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Non-cirrhotic Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12)
研究概览
简要总结
The purpose of the study is to study the combination of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1.
详细描述
In this open-label, single-center, head-to-head non-inferiority trial, treatment-naive or pegylated interferon treatment-experienced patients with GT1 infection were randomized to receive once-daily SOF 400 mg plus DCV 60 mg or SIM 150 mg for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR Never taken DAAs for HCV Patients must be able to understand and agree to/comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications No Liver Cirrhosis Liver fibrosis Metavir F3 APRI > 1,5 FIB4 > 3,25
排除标准
- •Infection with HCV other than GT-1 or subjects with mixed infections of any genotype Liver Cirrhosis Evidence of decompensated liver Subjects Infected with HIV-1 Hepatitis B virus (HBV) coinfection Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair Current or known history of cancer Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy Pregnancy or impossibility to use birth control methods by the couple, or breastfeeding Regular use of: erythromycin, clarithromycin, rifampicin, rifabutin, telithromycin, itraconazole, ketoconazole, posaconazole, fluconazole, voriconazole, dexamethasone, cisapride, rifapentine, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum perforatum), silymarin (Silybum marianum) and some antiarrhythmic drugs such as amiodarone
研究组 & 干预措施
Daclatasvir + Sofosbuvir
Daclatasvir 60 mg tablet + Sofosbuvir 400 mg tablet oral dosing once daily for 12 weeks
干预措施: Daclatasvir + Sofosbuvir (Drug)
Simeprevir + Sofosbuvir
Simeprevir 150 mg tablet + Sofosbuvir 400 mg tablet oral dosing once daily for 12 weeks
干预措施: Simeprevir + Sofosbuvir (Drug)
结局指标
主要结局
Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Non-cirrhotic Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12)
时间窗: At follow-up Week 12
SVR12 was defined as hepatitis C virus RNA levels to be \< lower limit of quantitation ie, 12 IU/mL at follow-up Week 12
次要结局
- Percentage of Subjects With Rapid Virologic Response at Week 4 (RVR)(Week 4)
- Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Non-cirrhotic Subjects With Relapse at Follow-up Week 12 (SVR12)(At follow-up Week 12)
- Treatment safety measured by the number of incidence of serious adverse event (SAEs), discontinuations due to adverse event (AEs), Grade 3/4 AEs and Grade 3/4 clinical laboratory abnormalities through the end of treatment.(From start of study treatment up to 7 days post last dose of study treatment)
- Percentage of Subjects With End of Treatment Response (EOTR)(Week 12)
研究者
Henrique Pott Junior
Dr. Henrique Pott-Junior
Federal University of São Paulo