Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1
This trial is active, not recruiting.
|Condition||hepatitis c, chronic|
|Treatment||telaprevir and sofosbuvir|
|Sponsor||University of Florida|
|Collaborator||Vertex Pharmaceuticals Incorporated|
|Start date||December 2013|
|End date||July 2014|
|Trial size||20 participants|
|Trial identifier||NCT01994486, 20132125|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Frequency of adverse events among subjects treated with Telaprevir and Sofosbuvir
time frame: 12 weeks
Minimum plasma concentration of Telaprevir in patients treated with Telaprevir and Sofosbuvir
time frame: Week 2 and Week 10
Male or female participants at least 18 years old.
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).
|Official title||Open-Label Study to Evaluate the Safety and Tolerability of Telaprevir in Combination With Sofosbuvir in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotype 1|
|Description||Starting on Day 1 and for up to 12 weeks, you will receive Telaprevir (TVR) and Sofosbuvir (SOF). You will take one (1) 400 mg tablet of SOF and 3 tablets (1125 mg each) of TVR. You should take these together by mouth every morning. You will take another 3 tablets (1125 mg each) of TVR by mouth 12 hours after you take your morning dose.|
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