Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multi center study of treatment-naive non-cirrhotic subjects with genotype 1 chronic Hepatitis C Virus. All subjects will receive telaprevir (TVR) in combination with sofosbuvir (SOF) for 12 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Vertex Pharmaceuticals Incorporated
• Treatments: Sofosbuvir

Criteria

Inclusion Criteria:

• Willing and able to provide informed consent

• BMI (Body Mass Index) ≥ 18 kg/m2

• HCV RNA quantifiable at screening and >1,000 IU/ml

• HCV treatment Naïve

• HCV genotype 1

• 7. Confirmation of chronic HCV infection documented by either: A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or A liver biopsy performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection

Exclusion Criteria:

• Current or prior history of any of the following:

Clinically-significant illness Cirrhosis 2. Screening ECG with clinically significant abnormalities

1. ALT > 10 x the upper limit of normal (ULN)

2. AST > 10 x ULN

3. Direct bilirubin > 1.5 x ULN

4. Platelets < 150,000/μL

5. HbA1c > 7.5%

6. Creatinine clearance (CLcr) < 60 mL /min, as calculated by the Cockcroft-Gault equation

7. Hemoglobin < 11 g/dL for female subjects; < 12 g/dL for male subjects.

8. Albumin < 3.1 g/dL

9. INR > 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR 4. Prior exposure to any approved or experimental HCV-specific direct-acting

5. Pregnant or nursing female or male with pregnant female partner.

6. Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis).

7. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).