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

NCT ID: NCT01585584

Last Updated: 2015-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-07-31

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Boceprevir

Group Type: EXPERIMENTAL

Boceprevir

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Sam Lee

Hepatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary Liver Unit

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

24411

Identifier Type: OTHER

Identifier Source: secondary_id

MISP #39897

Identifier Type: -

Identifier Source: org_study_id