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Trial record 10 of 25 for:    "Liver Cirrhosis" | "Peginterferon alfa-2a"

Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir

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ClinicalTrials.gov Identifier: NCT02113631
Recruitment Status : Completed
First Posted : April 14, 2014
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Yngve Falck-Ytter, Louis Stokes VA Medical Center

Brief Summary:
  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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Cirrhosis Drug: Telaprevir Drug: Boceprevir Drug: Peg-IFN Drug: Ribavirin Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir and Re-assessment of Treatment Duration in Patients With Chronic Hepatitis C
Study Start Date : September 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Boceprevir

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 Name: INCIVEK

Drug: Peg-IFN
Administration 45-180mcg in 0.5 ml solution s.c. weekly for 24-48 weeks
Other Name: Peg-Interferon alfa-2a, Pegasys

Drug: Ribavirin
Administration: 200 mg capsules; 800 mg-1200 mg daily for 24-48 weeks
Other Name: 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 Name: Victrelis

Drug: Peg-IFN
Administration 45-180mcg in 0.5 ml solution s.c. weekly for 24-48 weeks
Other Name: Peg-Interferon alfa-2a, Pegasys

Drug: Ribavirin
Administration: 200 mg capsules; 800 mg-1200 mg daily for 24-48 weeks
Other Name: Copegus




Primary Outcome Measures :
  1. Safety/Adverse Event Outcome Measure [ Time Frame: Up to 3 weeks ]
    Number of Participants with Serious and Non-Serious Adverse Events



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:

  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


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): NCT02113631


Locations
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United States, Ohio
Louis Stokes Cleveland VA medical center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Louis Stokes VA Medical Center
Investigators
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Principal Investigator: Yngve Falck-Ytter, MD Louis Stokes Cleveland VA medical center

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yngve Falck-Ytter, MD, Louis Stokes VA Medical Center
ClinicalTrials.gov Identifier: NCT02113631     History of Changes
Other Study ID Numbers: IRB #: 11064-H40
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Keywords provided by Yngve Falck-Ytter, Louis Stokes VA Medical Center:
Hepatitis C treatment,
Boceprevir,
Telaprevir,
Safety
Effectiveness
Head-to-head trial
Additional relevant MeSH terms:
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Peginterferon alfa-2a
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action