A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Asunaprevir

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Patients chronically infected with HCV Genotype 1b

• No previous exposure to any interferon formulation, Ribavirin (RBV), and HCV direct acting antiviral agent

• HCV RNA viral load ≥ 10,000 IU/mL at screening

• Seronegative for HIV and HBsAg

• BMI of 18-35 kg/m2, inclusive

• Patients with compensated cirrhosis are permitted

Exclusion Criteria:

• Infection with HCV other than genotype (GT) -1b

• Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

• Evidence of a medical condition contributing to chronic liver disease other than HCV

• Diagnosed or suspected hepatocellular carcinoma or other malignancies

• Uncontrolled diabetes or hypertension

• History of moderate to severe depression. Well-controlled mild depression is allowed

• Confirmed alanine aminotransferase (ALT) ≥ 5x Upper Limit of Normal (ULN)

• Confirmed platelet count < 50,000 cells/mm3

• Confirmed hemoglobin < 8.5 g/dL