A Phase 3, Open-Label Study with Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin with Chronic Hepatitis C Genotypes 1 or 4 Infection+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 13-Mar-12)Revised Protocol 02 incorporating Protocol Amendment 03 - Hallmark QUAD

Bristol-Myers Squibb International Corporation0 个研究点目标入组 520 人开始时间: 2012年4月20日最近更新: 2014年5月19日

适应症

试验速览

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•Males and females, = 18 years of age;
•HCV Genotype 1 or 4 who previously failed treatment with P/R, classified as previous null and partial responders based on previous therapy;
•HCV RNA = 10,000 IU/mL;
•Seronegative for HIV and HBsAg;
•Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population).
•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 500
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Prior treatment of HCV 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;
•Total bilirubin = 34 µmol/L (or = 2 mg/dL) unless subject has a documented history of Gilbert’s disease;
•ALT = 5x ULN;
•Albumin < 3.5 g/dL (35 g/L)
•AFP > 100 ng/mL (> 82.6 IU/mL) OR = 50 and = 100 ng/mL (= 41.3 IU/mL and = 82.6 IU/mL) requires a liver ultrasound and subjects with findings suspicious of HCC are excluded;
•ANC < 1.5 x 10 billion cells/L (< 1.2 x 10 billion cells/L for Black/African-Americans);
•Confirmed Platelets < 90 x 10 billion cells/L;
•Hemoglobin < 12 g/dL for females or < 13 g/dL for males;
•Any criteria that would exclude the subject from receiving P/R.

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