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) - Hallmark QUAD

Bristol-Myers Squibb International Corporation0 个研究点目标入组 496 人开始时间: 2012年5月29日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•? 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 ?mol/L (or ? 2 mg/dL) unless subject has a documented history of Gilbert?s disease;
•? Confirmed ALT ? 5x ULN;
•? Confirmed Albumin < 3.5 g/dL (35 g/L)
•? AFP > 100 ng/mL OR ? 50 and ? 100 ng/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.

发起方