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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Boceprevir
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Boceprevir, Hepatitis C Genotype 3

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Calgary Liver Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Boceprevir

Arm Description

Outcomes

Primary Outcome Measures

Sustained Virologic Response (SVR) at 24 Weeks Post 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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2012
Last Updated
August 22, 2015
Sponsor
University of Calgary
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01585584
Brief Title
Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment
Acronym
LeeG3
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 Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Boceprevir, Hepatitis C Genotype 3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boceprevir
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Boceprevir
Other Intervention Name(s)
VICTRELIS™, boceprevir capsules, 200 mg, Hepatitis C Virus (HCV) Protease Inhibitor
Intervention Description
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).
Primary Outcome Measure Information:
Title
Sustained Virologic Response (SVR) at 24 Weeks Post Treatment
Description
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.
Time Frame
24 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects will be eligible for the study if they meet the following inclusion criteria: 18 years of age or older Infected with HCV genotype 3 (mixed genotypes are NOT permitted) Have received at least 12 weeks of previous treatment with peginterferon-α + ribavirin Detectable serum HCV-RNA No significant co-morbid conditions Liver biopsy is not necessary 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: Significant comorbidities: uncontrolled psychiatric conditions including severe depression, cardiovascular, respiratory, renal or metabolic conditions, active carcinoma. Active substance abuse within the past 12 months Co-infection with hepatitis B or HIV Decompensated cirrhosis (Child-Pugh class B or C) 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 Lack of informed consent Previous null-responders (<2 log10 decrease at week 12 with previous PR therapy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Lee, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary Liver Unit
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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