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

NCT ID: NCT01994486

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-09-30

Brief 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.

Detailed 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.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telaprevir and Sofosbuvir

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

Group Type: EXPERIMENTAL

Telaprevir and Sofosbuvir

Intervention Type: DRUG

All subjects will have time to read and discuss IRB approved consent form prior to any study procedures. Following proper consenting, subjects will undergo physical exam including ECG and bloodwork prior to baseline visit. Subjects will return for research visits (vitals, collection of AEs, bloodwork, drug accountability) on Day 3, Weeks 1, 2, 3, 4, 6, 8, 10 and 12 of treatment and 4, 12, and 24 weeks after end of treatment. PK samples will be collected at week 2 and week 10.

Interventions

Telaprevir and Sofosbuvir

All subjects will have time to read and discuss IRB approved consent form prior to any study procedures. Following proper consenting, subjects will undergo physical exam including ECG and bloodwork prior to baseline visit. Subjects will return for research visits (vitals, collection of AEs, bloodwork, drug accountability) on Day 3, Weeks 1, 2, 3, 4, 6, 8, 10 and 12 of treatment and 4, 12, and 24 weeks after end of treatment. PK samples will be collected at week 2 and week 10.

Intervention Type: DRUG

Other Intervention Names

TVR; SOF

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

DAVID R NELSON, MD

Role: STUDY_DIRECTOR

University of Florida

Locations

UF Hepatology Research at CTRB

Gainesville, Florida, United States

Countries

United States

Other Identifiers

20132125

Identifier Type: -

Identifier Source: org_study_id