A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy with Genotype 1 Chronic Hepatitis C+Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, dated 14-May-12)

Bristol-Myers Squibb International Corporation0 个研究点目标入组 260 人开始时间: 2012年6月18日最近更新: 2013年12月16日

适应症

试验速览

暂无简介。

•HCV Genotype 1a or 1b;
•Males and females, = 18 years of age;
•HCV RNA > 10,000 IU/mL;
•Subjects with compensated cirrhosis are permitted.
•Advanced fibrosis (F3/F4) is capped at approximately 35% of the total treated population with a minimum of 20% F4 subjects.
•If no cirrhosis, a liver biopsy within 3 years prior to enrollment is required
•If cirrhosis is present, any prior liver biopsy is sufficient
•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 234
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 26

•Target Disease Exceptions
•Liver or any other transplant (other than cornea and hair):
•Evidence of a medical condition contributing to chronic liver disease other than HCV;
•Current or known history of cancer, (except situ carcinoma or adequately tx basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
•Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy;
•Subjects infected with HIV or HBV;
•Gastrointestinal disease impacting absorption of study drug;
•Uncontrolled diabetes or hypertension;
•Medication related
•Prior treatment of HCV with HCV direct acting agent (DAA);
•Any criteria that would exclude the subject from receiving RBV.
•Exclusion Laboratory results:
•Confirmed ANC < 1.5 billion cells/L (<1.2 billion cells/L for Black/African-Americans);
•Confirmed platelets < 90 billion cells/L;
•Confirmed hemoglobin < 12 g/dL for females or < 13 g/dL for males;
•ALT= 5 x ULN
•In subjects without cirrhosis, total bilirubin = 34 µmol/L (or = 2 mg/dL) unless subject has a documented history of Gilbert’s disease;
•In subjects with cirrhosis, total bilirubin = 26 µmol/L (or = 1.5 mg/dL);
•INR= 1.7
•QTcF or QTcB > 500 mSec
•CrCl= 50 mL/min
•AFP > 100 ng/mL OR
•AFP = 50 ng/mL and = 100 ng/mL requires a liver ultrasound (HCC are excluded)
•Albumin < 3.5 g/dL (35 g/L)

发起方