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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Telaprevir and Sofosbuvir Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arms and Interventions
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Arm Intervention/treatment
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994486


Locations
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United States, Florida
UF Hepatology Research at CTRB
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Vertex Pharmaceuticals Incorporated
Investigators
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Study Director: DAVID R NELSON, MD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01994486    
Other Study ID Numbers: 20132125
First Posted: November 25, 2013    Key Record Dates
Results First Posted: March 6, 2015
Last Update Posted: April 23, 2018
Last Verified: March 2018
Keywords provided by University of Florida:
HCV Genotype 1
Hepatitis C Virus Genotype 1
HCV
TVR
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic
Sofosbuvir
Antiviral Agents
Anti-Infective Agents