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

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sam Lee, University of Calgary Identifier:
First received: April 18, 2012
Last updated: August 22, 2015
Last verified: August 2015
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: 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:

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Sustained Virologic Response (SVR) at 24 Weeks Post Treatment [ Time Frame: 24 weeks after treatment ]
    Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment.

Enrollment: 11
Study Start Date: May 2012
Study Completion Date: July 2015
Primary Completion Date: December 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:
  • 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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01585584

Canada, Alberta
University of Calgary Liver Unit
Calgary, Alberta, Canada, T2N 4Z6
Sponsors and Collaborators
University of Calgary
Merck Sharp & Dohme Corp.
Principal Investigator: Samuel Lee, MD University of Calgary
  More Information

Responsible Party: Sam Lee, Hepatologist, University of Calgary Identifier: NCT01585584     History of Changes
Other Study ID Numbers: MISP #39897
24411 ( Other Identifier: University of Calgary )
Study First Received: April 18, 2012
Results First Received: August 22, 2015
Last Updated: August 22, 2015

Keywords provided by University of Calgary:
Hepatitis C Genotype 3

Additional relevant MeSH terms:
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors processed this record on April 28, 2017