A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naïve or Prior Relapsers to Alfa/RBV Therapy (the STRUCTURE Study)
A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naïve or Prior Relapsers to Alfa/RBV Therapy (the STRUCTURE Study)
The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin
Inclusion Criteria:
Exclusion Criteria:
Infection with Hepatitis C virus (HCV) other than Genotype-1b
Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)-1/HIV-2 antibody test at screening
Evidence of chronic liver disease caused by diseases other than chronic HCV infection
Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
Current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Laboratory values:
Buenos Aires, Buenos Aires 1119, Argentina
Buenos Aires, Buenos Aires 1221, Argentina
Buenos Aires, Buenos Aires C1181, Argentina
Capital Federal, Buenos Aires C1405BCK, Argentina
Prov de Santa Fe, Santa Fe Province 2000, Argentina
Zafed, 13110, Israel
Kitakyushu-shi, Fukuoka 8028533, Japan
Higashiibaraki-gun, Ibaraki 3313193, Japan
Kawasaki-shi, Kanagawa 2138587, Japan
Minato-ku, Tokyo 1058470, Japan
Musashino-shi, Tokyo 1808610, Japan
Sumida-ku, Tokyo 1308575, Japan
Tanabe-shi, Wakayama 6468558, Japan
Kaohsiung, Taiwan 80756, Taiwan