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

Completed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT01994486

Run by

University of Florida

People needed

20

Starts

2013-12-01

Expected to finish

2014-09-01

Last updated by the study team

2018-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Current or prior history of any of the following:
• Clinically-significant illness Cirrhosis 2. Screening ECG with clinically significant abnormalities
• ALT > 10 x the upper limit of normal (ULN)
• AST > 10 x ULN
• Direct bilirubin > 1.5 x ULN
• Platelets < 150,000/μL
• HbA1c > 7.5%
• Creatinine clearance (CLcr) < 60 mL /min, as calculated by the Cockcroft-Gault equation
• Hemoglobin < 11 g/dL for female subjects; < 12 g/dL for male subjects.
• Albumin < 3.1 g/dL
• 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
• Pregnant or nursing female or male with pregnant female partner.
• Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis).
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

Where it is running

• UF Hepatology Research at CTRB — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.