This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir in patients with Hepatitis C (HCV) genotype2,3,6. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12，the other group will receive the same dose for 24 weeks.
Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12,the other group will receive the same dose for 24 weeks.
Beijing Ditan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGLiuzhou General Hospital
Liuzhou, Guangxi, China
RECRUITINGThe first hospital of JILIN University.
Changchun, Jilin, China
RECRUITINGPercentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12）
SVR12 is defined as HCV RNA \< the lower limit of quantification (LLOQ; ie, \< 15 IU/mL) 12 weeks following the last dose of study drug.
Time frame: Posttreatment Week 12
Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)
SVR4 is defined as HCV RNA \< LLOQ at 4 weeks following the last dose of study drug.
Time frame: Posttreatment Week 4
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The First Affiliated Hospital Of Guangxi Medical University
Guangxi, Nanning, China
RECRUITING