NCT01995266已完成3 期
A Phase 3, Open-Label Study With Daclatasvir And Asunaprevir (DUAL) for Subjects With Genotype 1b Chronic Hepatitis C (HCV) Infection Who Are Intolerant or Ineligible to Interferon Alfa Therapies With or Without Ribavirin
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2014年2月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24)
研究概览
简要总结
Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Males and females, ≥ 18 years of age
- •Subjects chronically infected with HCV Genotype (GT)-1b only as documented by positive HCV RNA and anti-HCV antibody at screening and either:
- •Positive anti-HCV antibody, HCV RNA or positive HCV genotype test at least 6 months prior to screening
- •Liver biopsy consistent with chronic HCV infection (evidence of fibrosis and/or inflammation)
- •Subjects who are intolerant to previous therapy with Interferon Alfa (IFNα) either with or without Ribavirin (RBV) (I±R)(independent of previous response to therapy) or ineligible for I±R and who meet one of the criteria below:
- •Anemia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in hemoglobin to < 8.5 g/dL during therapy (documented); the I±R ineligibles are subjects who have a screening hemoglobin < 10.0 g/dL and ≥ 8.5 g/dL
- •Neutropenia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in absolute neutrophil count (ANC) to < 0.5 x 10(9) during therapy (documented); the I±R ineligibles are subjects who have a screening ANC < 1.5 x 10(9) cells/L and ≥ 0.5 x 10(9) cells/L
- •Thrombocytopenia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in platelet counts < 25,000 cells/mm3 during therapy (documented); the I±R ineligibles are subjects who have a screening platelet count of < 90 x 10(9) cells/L and ≥ 50 x 10(9) cells/L
- •HCV RNA ≥ 10,000 IU/mL
- •Seronegative for Human Immunodeficiency Virus (HIV) and hepatitis B surface antigen (HBsAg)
- •Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. BMI = weight (kg)/ [height(m)]2 at screening
- •Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 40%). If a subject does not have cirrhosis, a liver biopsy within three years prior to enrollment is required to demonstrate the absence of cirrhosis. If cirrhosis is present, any prior liver biopsy is sufficient. For countries where liver biopsy is not required prior to treatment and where noninvasive imaging tests (Fibroscan® ultrasound) are approved for staging of liver disease, non-invasive imaging test results may be used to assess the extent of liver disease
排除标准
- •Prior treatment with HCV direct acting antiviral (DAA)
- •Evidence of a medical condition contributing to chronic liver disease other than HCV
- •Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
- •Diagnosed or suspected hepatocellular carcinoma or other malignancies
- •Uncontrolled diabetes or hypertension
- •History of moderate to severe depression. Well-controlled mild depression is allowed
- •Total bilirubin ≥ 34 µmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
- •Confirmed alanine aminotransferase (ALT) ≥ 5 x upper limit of normal (ULN)
- •Confirmed albumin < 3.5 g/dL (35 g/L)
- •Alpha-fetoprotein (AFP) > 100 ng/mL OR ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of hepatocellular carcinoma (HCC) are excluded
- •Confirmed hemoglobin < 8.5 g/dL
- •Confirmed ANC < 0.5 x 10(9) cells/L
- •Confirmed platelet count < 50,000 cells/mm3
研究组 & 干预措施
Asunaprevir + Daclatasvir
Experimental
Asunaprevir 100mg soft capsule by mouth twice daily for 24 weeks and
Daclatasvir 60mg tablet by mouth once daily for 24 weeks
干预措施: Asunaprevir (Drug)
Asunaprevir + Daclatasvir
Experimental
Asunaprevir 100mg soft capsule by mouth twice daily for 24 weeks and
Daclatasvir 60mg tablet by mouth once daily for 24 weeks
干预措施: Daclatasvir (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24)
时间窗: 24 Weeks after treatment discontinuation (Follow-up Week 24)
SVR was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) \< lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 24.
次要结局
- Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 12 (SVR12)(12 Weeks after treatment discontinuation (Follow-up Week 12))
- Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Death, and AEs Leading to Discontinuation(7 days after treatment discontinuation)
- Percentage of Participants With SVR24 by the rs12979860 Single Nucleotide Polymorphisms (SNP) in the IL 28B Gene at Post-Treatment Follow-up Week 24(24 Weeks after treatment discontinuation (Follow-up Week 24))
- Percentage of Participants With HCV RNA< LLOQ Target Not Detected at the End of Treatment (Week 24)(Week 24 (End-of Treatment))
- Number of Participants With Rapid Virologic Response (RVR)(Treatment Week 4)
- Percentage of Participants With Complete Early Virologic Response (cEVR)(Treatment Week 12)
- Number of Participants With Extended Rapid Virologic Response (eRVR)(Treatment Week 4 and Week 12)
- Number of Participants With HCV RNA < LLOQ Target Detected or Not Detected at the End of Treatment (Week 24)(Week 24 (End-of Treatment))
- Number of Participants With Virologic Response (VR) at Treatment Week 4 and 12(Treatment Week 4 and 12)
研究者
研究点 (1)
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