Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Intervention: Asunaprevir; Daclatasvir
Intervention MeSH terms: Asunaprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  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:

               1. Positive anti-HCV antibody, HCV RNA or positive HCV genotype test at least 6
                  months prior to screening

                  or

               2. 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:

               1. 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

                  OR

               2. 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

                  OR

               3. 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

        Exclusion Criteria:

          -  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