Clinical Protocol AI447-029 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 - Open-Label Study: Asunaprevir/Daclatasvir + Peginterferon Alfa/Ribavirin

Bristol-Myers Squibb0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月29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). 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 non-invasive 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.

•* Prior treatment of HCV with HCV direct acting agent (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
•* Confirmed ALT * 5x ULN;
•* Confirmed Albumin * 3.5 g/dL (35 g/L)
•* Confirmed ANC < 0.5 x 109 cells/L
•* AFP > 100 ng/mL OR * 50 and * 100 mg/mL requires a liver ultrasound and subjects with
•findings suspicious of HCC are excluded;
•* Neutrophil count < 1500 cells/*L (<1,200 cells/*L for Black/African-Americans);
•* Platelet count < 90,000 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;
•* Hematologic, biochemical and serologic criteria (growth factors may not be used to achieve trial
•entry requirements)

发起方

Bristol-Myers Squibb