Overview

This trial is active, not recruiting.

Condition hepatitis c, chronic
Treatment telaprevir and sofosbuvir
Phase phase 2
Sponsor University of Florida
Collaborator Vertex Pharmaceuticals Incorporated
Start date December 2013
End date July 2014
Trial size 20 participants
Trial identifier NCT01994486, 20132125

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.
telaprevir and sofosbuvir TVR
All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10.

Primary Outcomes

Measure
Frequency of adverse events among subjects treated with Telaprevir and Sofosbuvir
time frame: 12 weeks

Secondary Outcomes

Measure
Minimum plasma concentration of Telaprevir in patients treated with Telaprevir and Sofosbuvir
time frame: Week 2 and Week 10

Eligibility Criteria

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).

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University of Florida.