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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01585584
Recruitment Status : Completed
First Posted : April 26, 2012
Results First Posted : September 21, 2015
Last Update Posted : September 21, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sam Lee, University of Calgary

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Drug: Boceprevir Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Boceprevir
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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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)

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 identifier (NCT number): 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

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 )
First Posted: April 26, 2012    Key Record Dates
Results First Posted: September 21, 2015
Last Update Posted: September 21, 2015
Last Verified: August 2015

Keywords provided by Sam Lee, 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