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

Triple-Therapy With PegInterferon α-2b + Ribavirin + Boceprevir in Patients With HCV Genotype 3 Who Previously Failed Treatment With PegInterferon α + Ribavirin

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).

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Drug: Boceprevir

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
• Enrollment (Actual): 11
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary Liver Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: VICTRELIS™; boceprevir capsules, 200 mg; Hepatitis C Virus (HCV) Protease Inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks after treatment

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Samuel Lee, MD, University of Calgary

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 26, 2012

Study Record Updates

• Last Update Posted (Estimate): September 21, 2015
• Last Update Submitted That Met QC Criteria: August 22, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Hepatitis C Genotype 3; Boceprevir
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors
• Other Study ID Numbers: MISP #39897; 24411 (Other Identifier: University of Calgary)