The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
55
Tablets, Oral, 10 mg, daily, 24-48 weeks
Tablets, Oral, 60 mg, daily, 24-48 weeks
Tablets, Oral, 0 mg, daily, 48 weeks
Local Institution
Chiba, Chiba, Japan
Local Institution
Kurume-Shi, Fukuoka, Japan
Local Institution
Okayama, Okayama-ken, Japan
Local Institution
Osaka, Osaka, Japan
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA \<15 IU/mL, the lower limit of detection at both Weeks 4 and 12.
Time frame: From Week 4 up to Week 12
Percentage of Participants With Rapid Virologic Response (RVR)
RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA \<15 IU/mL, the lower limit of detection at Week 4.
Time frame: Week 4
Percentage of Participants With a Complete Early Virologic Response (cEVR)
cEVR was defined as hepatitis C virus RNA \<15 IU/mL at Week 12.
Time frame: Week 12
Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24
SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA \<15 IU/mL at follow-up Weeks 12 and 24.
Time frame: Follow up Week 12, Follow up Week 24
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Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Local Institution
Osaka, Osaka, Japan
Local Institution
Musashino-Shi, Tokyo, Japan