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

Primary Purpose

Hepatitis C, Chronic

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Telaprevir and Sofosbuvir

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring HCV Genotype 1, Hepatitis C Virus Genotype 1, HCV, TVR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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
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).

Sites / Locations

UF Hepatology Research at CTRB

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telaprevir and Sofosbuvir

Arm 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.

Outcomes

Primary Outcome Measures

Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir

Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported.

Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks

The number of subjects who experienced Grade 3 anemia. Complete blood count was collected at baseline, week 2, week 4, week 8, week 12, week 18, and week 24. Incidence of moderate anemia (Grade 3) observed in the study treatment period.

Secondary Outcome Measures

Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007

Sparse Pharmokinetic blood samples were collected at Week 2 and Week 10 (prior to daily dose) in patients treated with Telaprevir and Sofosbuvir.

Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen

Plasma HCV RNA levels were assessed using the COBAS TaqMan HCV RNA assay test (v2.0; Roche Diagnostics, Indianapolis, IN, USA; LLOQ=25 IU/mL;limit of detection =15 IU/mL)

Proportion of Subjects With Viral Relapse

Defined as Subjects who have undetectable HCV RNA at end of treatment, and confirmed detectable HCV RNA between end of treatment and SVR12 planned assessment time point.

Full Information

NCT ID

NCT01994486

First Posted

November 12, 2013

Last Updated

March 21, 2018

Sponsor

University of Florida

Collaborators

Vertex Pharmaceuticals Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01994486

Brief Title

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

Acronym

STEADFAST

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

Vertex Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

Keywords

HCV Genotype 1, Hepatitis C Virus Genotype 1, HCV, TVR

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Telaprevir and Sofosbuvir

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Telaprevir and Sofosbuvir

Other Intervention Name(s)

TVR, SOF

Intervention Description

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.

Primary Outcome Measure Information:

Title

Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir

Description

Time Frame

12 weeks-January 3, 2014- April 10, 2014

Title

Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks

Description

Time Frame

1/3/2014-4/10/2014

Secondary Outcome Measure Information:

Title

Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007

Description

Sparse Pharmokinetic blood samples were collected at Week 2 and Week 10 (prior to daily dose) in patients treated with Telaprevir and Sofosbuvir.

Time Frame

1/17/2014-3/26/2014

Title

Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen

Description

Plasma HCV RNA levels were assessed using the COBAS TaqMan HCV RNA assay test (v2.0; Roche Diagnostics, Indianapolis, IN, USA; LLOQ=25 IU/mL;limit of detection =15 IU/mL)

Time Frame

6/16/2014-7/2/2014

Title

Proportion of Subjects With Viral Relapse

Description

Defined as Subjects who have undetectable HCV RNA at end of treatment, and confirmed detectable HCV RNA between end of treatment and SVR12 planned assessment time point.

Time Frame

1/3/2014-9/8/2014

Other Pre-specified Outcome Measures:

Title

Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose

Description

Subjects who complete assigned treatment and have undetectable HCV RNA at 12 weeks after the last planned dose of study treatment

Time Frame

4/22/2014-5/6/2014

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

DAVID R NELSON, MD

Organizational Affiliation

University of Florida

Official's Role

Study Director

Facility Information:

Facility Name

UF Hepatology Research at CTRB

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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