Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
With
Astellas Pharma US, Inc.
This is a multi-center, randomized, investigator and subject blinded, placebo-controlled eight week study, including a four week treatment period and a four week follow-up period. Three cohorts of HCV positive subjects will be studied in a sequential manner.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The following criteria is a brief summary of Criterion required for trial participation.
Has chronic hepatitis C virus infection and has previously received at least three months of treatment with any approved therapy and failed to respond, relapsed or did not tolerate therapy
Has positive HCV RNA by RT-PCR
Has abnormal ALT levels (at least 2 X ULN)
Has liver biopsy within past 2 years consistent with chronic hepatitis, no evidence of non-alcoholic steatohepatitis or cirrhosis, and at least mild inflammation
Has normal liver function indicated by: PT =\< 2 sec. prolonged compared to the ULN, Albumin \>= 3.5 g/dL, Total bilirubin =\< 1.5 mg/dL
ANA titer =\< 1:160
You may not be if
Has positive skin test for tuberculosis
Has ALT value \>= 300 IU/L
Has abnormal hematological parameters indicated by: ANC \< 1500/mm3 and Platelets \< 100,000/mm3
Has creatinine \> 1.5 X ULN
AFP \> 50 ng/mL and evidence of hepatocellular carcinoma on ultrasound
Is a carrier of the hepatitis B surface antigen (HBsAg), positive for HIV-1 and/or HIV-2 antibodies
