Evaluation of Safety Tolerability and Antiviral Activity of ACH-0143102 Plus RBV Treatment Naive HCV GT1b Subjects

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in GT1b, treatment-naive, HCV subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Achillion Pharmaceuticals; Alexion Pharmaceuticals
• Treatments: Antiviral Agents; Ribavirin

Criteria

Inclusion Criteria:

• Males and females 18 years and older

• Clinical diagnosis of hepatitis C with genotype 1b

• Chronic hepatitis C treatment naive subjects

• IL28B genotype CC

• HCV RNA > 10000 IU/mL at screening

• Females must be willing to use two effective methods of contraception during dosing period and for six months after the last dose of ribavirin.

• Male patients must be willing to use an effective barrier method of contraception throughout the dosing period and for six months after the last dose of ribavirin. Males must agree to not donate sperm while enrolled in the study and for six months after the last dose of ribavirin.

• Willing to participate in all study activities and all study requirements.

Exclusion Criteria:

• BMI>36

• Pregnant or nursing females

• Clinically significant laboratory abnormalities at screening

• Previous participation in a clinical trial with protease inhibitor and/or NS5A inhibitor

• HIV infection or other liver diseases

• Positive Hepatitis B Surface Antigen

• Liver cirrhosis

• Uncontrolled psychiatric disease

• Clinical evidence of chronic cardiac disease

• History of malignancy of any organ system within 5 years