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

University of Calgary

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Boceprevir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01585584

24411 (Other Identifier)

MISP #39897

Details and patient eligibility

About

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).

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

Boceprevir

Experimental group

Treatment:

Drug: Boceprevir