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)Revised Protocol 03, incorporating Amendment 09 (version 1.0, dated 09-Jul-2013)+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 21-Jun-12) - The STRUCTURE Study

Bristol-Myers Squibb International Corporation0 个研究点目标入组 585 人开始时间: 2012年12月18日最近更新: 2014年12月8日

适应症

试验速览

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•Patients chronically infected with HCV GT-1b
•Naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks)
•HCV RNA viral load = 100,000 IU/mL at screening
•Patients with compensated cirrhosis are permitted
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 527
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 58

•Infection with HCV other than GT-1b
•Positive HBsAg or 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: hemoglobin < 12.0 g/dL (males) or < 11.0 g/dL (females), platelets <90,000/mm³, total serum bilirubin = 2 mg/dL (unless due to Gilbert’s disease)

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