Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir

March 13, 2017 updated by: Yngve Falck-Ytter, Louis Stokes VA Medical Center

Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir and Re-assessment of Treatment Duration in Patients With Chronic Hepatitis C

  1. The primary objective is to study the comparative effectiveness and tolerability of boceprevir vs. telaprevir in HCV treatment, within the VA population.

  2. The secondary objective:

    • Resource use: recording of differences in resource use, such as direct costs (e.g., drug acquisition costs) and other indirect cost (e.g., staff utilization etc.) as the study will not only derive data by comparing those two drugs but also study the effect on different treatment lengths.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized clinical trial comparing the effectiveness and safety of boceprevir and telaprevir.

Recruitment of current eligible subjects will occur during their regular appointments at the Hepatitis C clinic. Eligible patients will have already been cleared for Hepatitis C treatment through their screening period which is including blood work, liver biopsy, urine collection/analysis, pregnancy screening and behavioral/mental health screening. On one of their standard visits to the Hepatitis C clinic, the health care provider(who is also research staff) or research staff will provide a consent form that the patient may take home and read more about the study.

On the day of enrollment, which will also be the first day of treatment, health care providers within the Hepatitis C clinic will describe the study to the patient or refer them to one of the research for completion of these tasks. The consent form will be explained in detail at this meeting, and the patient will have the opportunity to ask questions and make comments about the study.

Study subjects will initially be stratified into 6 groups (1a. treatment naives without cirrhosis and b. with compensated cirrhosis ; 2a. prior treatment experienced non-responders without cirrhosis and b. with cirrhosis; 3a. prior treatment experienced relapsers without cirrhosis and b. with cirrhosis). Patients in each of these groups will be randomized using random number table and allocation concealment will be achieved by using serially numbered, opaque, sealed envelopes into one of two study groups. The first group will receive boceprevir with Peg-IFN and ribavirin as indicated by package insert, and the second group will receive telaprevir with Peg-IFN and ribavirin as indicated by its package insert. All other stratified groups will receive protease inhibitor therapy as indicated by the FDA product labeling.

Safety and effectiveness assessments will be conducted at study entry, PI therapy week 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 42 and 48, if applicable. Those are SOC visits during the treatment period and they will include blood tests, complete review of systems, and physical exams. Patients in all groups will be assessed for sustained viral response (SVR) at 12 and 24 weeks after the last dose of the medication is administered.

Identical to SOC, safety and effectiveness assessments will be determine by health care providers and the adjudication committee, the latter of which will be unaware of the treatment arm of the patients. Members of the adjudication committee will be independent of the treating clinicians, and will be responsible for adjudicating the following outcomes:

  • Viral response
  • Adverse effects
  • Decision regarding treatment discontinuation, based on adverse effect or virological failure

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Louis Stokes Cleveland VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At least 18 years of age
  2. Have HCV genotype 1 infection and evidence of chronic hepatitis, as confirmed by a liver biopsy completed within three years prior to enrollment in the study, patients with cirrhosis will not need to undergo biopsy. Patients with compensated liver cirrhosis will be eligible. Patients who have previously been treated under standard of care (Peg-IFN, Ribavrin) and were non-responders, partial responders, or relapsers will also be eligible.
  3. Platelet count >60,000/mm3
  4. Absolute neutrophil count > 1000/mm3
  5. Hemoglobin >11.0 g/dL for females or >12.0 g/dL for males
  6. Serum creatinine </=1.5 mg/dL
  7. Adequately controlled DM
  8. Normal or adequately controlled TSH on prescription medication
  9. All other clinical laboratory values within normal limits, unless judged not clinically significant by the investigator
  10. Sterile or infertile (defined as vasectomy, tubal ligation, postmenopausal, or hysterectomy), or willing to use an approved method of double-barrier contraception (hormonal plus barrier or barrier plus barrier, eg, diaphragm plus condom) from the time of first dose administration until 6 months after the last dose
  11. Capable of understanding instructions, adhering to study schedules and requirements, and willing to provided informed consent

Exclusion Criteria:

  1. Positive HIV or HbsAg serology
  2. Severe psychiatric or neuropsychiatric disorders including, but not limited to uncontrolled severe depression, history of suicidal ideations or suicide attempt(s), as determinate by SOC psychological evaluation 3 History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic (including severe retinopathy), or immune mediated disease

4. Chronic hepatic diseases other than hepatitis C 5. Organ or bone marrow transplant 6. Chronic (greater than 30 days) use of immunosuppressive medications including steroids in doses equivalent to 10 mg of prednisone or higher, 30 days prior to and anytime during the course of the study 7. Female patients who are breast-feeding or have a positive pregnancy test at any time during the study 8. Males whose female partners are pregnant 9. Patients who have had a malignancy diagnosed and/or treated within the past 3 years, except for localized squamous or basal cell cancers treated by local excision 10. Patients who have participated in a clinical trial and have received an investigational drug within 30 days prior to screening 11. Current alcoholism or drug addiction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Telaprevir
Telapravir was administer with Peg-IFN and Ribavirin as per package insert Dose Telaprevir : PO, tablet 1125 mg BID for 12 weeks
Drug: Telaprevir
Other Names:
  • INCIVEK
Drug: Peg-IFN
Administration 45-180mcg in 0.5 ml solution s.c. weekly for 24-48 weeks
Other Names:
  • Peg-Interferon alfa-2a, Pegasys
Drug: Ribavirin
Administration: 200 mg capsules; 800 mg-1200 mg daily for 24-48 weeks
Other Names:
  • Copegus
Active Comparator: Boceprevir
Boceprevir was administer with Peg-IFN and Ribavirin as per package insert Dose Boceprevir PO capsule, 800mg TID for up to 44 weeks
Drug: Boceprevir
Other Names:
  • Victrelis
Drug: Peg-IFN
Administration 45-180mcg in 0.5 ml solution s.c. weekly for 24-48 weeks
Other Names:
  • Peg-Interferon alfa-2a, Pegasys
Drug: Ribavirin
Administration: 200 mg capsules; 800 mg-1200 mg daily for 24-48 weeks
Other Names:
  • Copegus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety/Adverse Event Outcome Measure
Time Frame: Up to 3 weeks
Number of Participants with Serious and Non-Serious Adverse Events
Up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louis Stokes VA Medical Center

Investigators

  • Principal Investigator: Yngve Falck-Ytter, MD, Louis Stokes Cleveland VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

March 30, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #: 11064-H40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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