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Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment (LeeG3)

This study is currently recruiting participants.
Verified May 2013 by University of Calgary
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Sam Lee, University of Calgary
ClinicalTrials.gov Identifier:
NCT01585584
First received: April 18, 2012
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to test the potential antiviral efficacy of triple-combination therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype 3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).


Condition Intervention Phase
Hepatitis C
 Drug: Boceprevir
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Triple-Therapy With PegInterferon α-2b + Ribavirin + Boceprevir in Patients With HCV Genotype 3 Who Previously Failed Treatment With PegInterferon α + Ribavirin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Sustained Virologic Response (SVR) that will be evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
    Futility rules: HCV RNA ≥ 100 IU/mL at treatment week 12 or HCV RNA > the limit of detection (LoD) at treatment Week 24. If the HCV RNA is > LoD but < limit of quantification (LoQ), then the viral load test will be repeated within approximately 2 weeks. If the result from the repeat test is > LoD, futility is met and study therapy is discontinued.


Secondary Outcome Measures:
  • Evaluate SVR-12 measured 12 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 12. [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
    Virologic breakthrough is defined as an initial undetectable HCV RNA reading at any time point during the study that subsequently becomes > LoQ while on therapy. If the HCV RNA is > LoQ and <1000 IU/mL, then the viral load test will be repeated within approximately 2 weeks. If the result from the repeat test is > LoQ, the definition of breakthrough is met and study therapy is discontinued.

  • Viral resistance evaluations will be performed using archived plasma samples collected at pre-specified time points during the study. [ Time Frame: During 24 weeks of treatment and 24 weeks post treatment follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Boceprevir Drug: Boceprevir
All patients will receive a 4-week lead-in with Peginterferon and Ribavirin therapy, followed by 24 weeks of Pegetron 1.5microg/kg + weight-based ribavirin + boceprevir 800mg tid. HCV RNA (Cobas TaqMan) will be measured at baseline and at treatment weeks 4, 6,8,12,16,20,24 and 28, and post-treatment weeks 12 and 24 (to obtain SVR-12 and SVR-24 results).
Other Names:
  • VICTRELIS™
  • boceprevir capsules, 200 mg
  • Hepatitis C Virus (HCV) Protease Inhibitor

Detailed Description:

i) Obtain preliminary information on the association between important baseline and on-treatment factors and SVR in this patient population. Variables to be examined may include gender, age, advanced fibrosis or cirrhosis (F3 or F4 estimated by Fibroscan), baseline viral load, RVR, wk 8 viral load, end-of-treatment viral response.

ii) Evaluate adverse events. iii) Evaluate viral resistance.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects will be eligible for the study if they meet the following inclusion criteria:

    1. 18 years of age or older
    2. Infected with HCV genotype 3 (mixed genotypes are NOT permitted)
    3. Have received at least 12 weeks of previous treatment with peginterferon-α + ribavirin
    4. Detectable serum HCV-RNA
    5. No significant co-morbid conditions
    6. Liver biopsy is not necessary
    7. Cirrhotic patients will be eligible to participate if Child-Pugh class A (maximum 15% of subjects)

Exclusion Criteria:

  • Subjects will be excluded from participation in this study if the following conditions are present:

    1. Significant comorbidities: uncontrolled psychiatric conditions including severe depression, cardiovascular, respiratory, renal or metabolic conditions, active carcinoma.
    2. Active substance abuse within the past 12 months
    3. Co-infection with hepatitis B or HIV
    4. Decompensated cirrhosis (Child-Pugh class B or C)
    5. Significant cytopenia - any of the following: platelets <80 x 109/L, neutropenia <1.2 x 103/L, Hb <120 g/l for men or 110 g/l for women
    6. Lack of informed consent
    7. Previous null-responders (<2 log10 decrease at week 12 with previous PR therapy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585584

Contacts
Contact: Samuel Lee, MD 403-220-8966 samlee@ucalgary.ca
Contact: Leah Kilvert, RN 403-220-7506 l.kilvert@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Liver Unit Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Sam Lee, MD         samlee@ucalgary.ca    
Principal Investigator: Sam Lee, MD            
Sponsors and Collaborators
University of Calgary
Merck
Investigators
Principal Investigator: Samuel Lee, MD University of Calgary
  More Information

No publications provided

Responsible Party: Sam Lee, Hepatologist, University of Calgary
ClinicalTrials.gov Identifier: NCT01585584     History of Changes
Other Study ID Numbers: MISP #39897, 24411
Study First Received: April 18, 2012
Last Updated: May 14, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Boceprevir
Hepatitis C Genotype 3

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Protease Inhibitors
Ribavirin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013