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

Hepatitis C Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585584
• Other study ID #: MISP #39897
• Secondary ID: 24411
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2012
• Last updated: August 22, 2015
• Start date: May 2012
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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-a + 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C

Intervention

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).

Locations

Country	Name	City	State
Canada	University of Calgary Liver Unit	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No