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

University of Florida

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Telaprevir and Sofosbuvir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01994486

20132125

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Telaprevir and Sofosbuvir

Experimental group

Description:

All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.

Treatment:

Drug: Telaprevir and Sofosbuvir