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

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ClinicalTrials.gov Identifier: NCT01994486
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : March 6, 2015
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE November 12, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE February 20, 2015
Results First Posted Date  ICMJE March 6, 2015
Last Update Posted Date April 23, 2018
Study Start Date  ICMJE December 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir [ Time Frame: 12 weeks-January 3, 2014- April 10, 2014 ]
    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 [ Time Frame: 1/3/2014-4/10/2014 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
Frequency of adverse events among subjects treated with Telaprevir and Sofosbuvir [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
  • Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007 [ Time Frame: 1/17/2014-3/26/2014 ]
    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 [ Time Frame: 6/16/2014-7/2/2014 ]
    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 [ Time Frame: 1/3/2014-9/8/2014 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
Minimum plasma concentration of Telaprevir in patients treated with Telaprevir and Sofosbuvir [ Time Frame: Week 2 and Week 10 ]
All patients will participate in a sparse PREDOSE PK sampling at wk 2 and wk 10
Current Other Pre-specified Outcome Measures
 (submitted: March 21, 2018)
Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose [ Time Frame: 4/22/2014-5/6/2014 ]
Subjects who complete assigned treatment and have undetectable HCV RNA at 12 weeks after the last planned dose of study treatment
Original Other Pre-specified Outcome Measures
 (submitted: November 19, 2013)
Number of subjects with Sustained Virologic Response [ Time Frame: 12 weeks ]
This study will assess the antiviral efficacy (SVR 12) of combination treatment with telaprevir and sofosbuvir administered for 12 weeks.
 
Descriptive Information
Brief Title  ICMJE Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C, Chronic
Intervention  ICMJE Drug: 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.
Other Names:
  • TVR
  • SOF
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: Telaprevir and Sofosbuvir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994486
Other Study ID Numbers  ICMJE 20132125
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Vertex Pharmaceuticals Incorporated
Investigators  ICMJE
Study Director: DAVID R NELSON, MD University of Florida
PRS Account University of Florida
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP