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

Phase 3

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Boceprevir

• Registration Number: NCT01585584
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-26
• Study Start: 2012-05
• Primary Completion: 2014-12
• Study Completion: 2015-07
• Status Verified: 2015-08
• Results First Submitted: 2015-08-22
• Results First Submitted QC: 2015-08-22
• Last Update Submitted: 2015-08-22
• Results First Posted: 2015-09-21
• Last Update Posted: 2015-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Boceprevir	Boceprevir	-

Primary Outcome Measures

Name	Time	Method
Sustained Virologic Response (SVR) at 24 Weeks Post Treatment	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.

Trial Locations

Locations (1)

University of Calgary Liver Unit; 🇨🇦 Calgary, Alberta, Canada