An Open-label, Multicenter, Efficacy and Safety Study of Pegasys® Plus Ribavirin in Patients With Chronic HCV Infection Who Are Unable to Tolerate or Who Do Not Respond to 12 Weeks of Therapy With PEGIntron ® Plus Ribavirin
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 57
- Primary Endpoint
- Number of Pegasys and Ribavirin Therapy Completers
Study Overview
Brief Summary
This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is >100 individuals.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients at least 18 years of age
- •CHC infection, genotype 1
- •unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks of treatment
- •use of 2 forms of contraception during the study in both men and women
Exclusion Criteria
- •women who are pregnant or breast-feeding
- •medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
- •patients with decompensated cirrhosis
- •patients receiving any systemic antiviral therapy or investigational drug, other than PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug
Arms & Interventions
Non-Responders
Participants will receive Pegasys 180 micro grams (µg or mcg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day [(mg/day), < or >=75 kilogram (Kg) body weight, respectively], orally in divided doses for 60 weeks.
Intervention: peginterferon alfa-2a [Pegasys] (Drug)
Non-Tolerators
Participants will receive Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Intervention: peginterferon alfa-2a [Pegasys] (Drug)
Non-Tolerators
Participants will receive Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Intervention: Ribavirin (Drug)
Non-Responders
Participants will receive Pegasys 180 micro grams (µg or mcg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day [(mg/day), < or >=75 kilogram (Kg) body weight, respectively], orally in divided doses for 60 weeks.
Intervention: Ribavirin (Drug)
Outcomes
Primary Outcomes
Number of Pegasys and Ribavirin Therapy Completers
Time Frame: 36 weeks for Non-Tolerators and 60 weeks for Non-Responders
Therapy completers were defined as all participants who had demonstrable viremia after 12 weeks of Pegasys plus ribavirin therapy (who were to be discontinued for lack of efficacy), non-tolerators who completed 36 weeks of Pegasys plus ribavirin therapy, and non-responders who completed 60 weeks of Pegasys plus ribavirin therapy. Study completers included all participants who completed the planned treatment period (36 weeks for non-tolerators and 60 weeks for non-responders) and the 24-week treatment-free follow-up period and participants in either group who were prematurely discontinued per protocol due to insufficient therapeutic response at Week 12.
Secondary Outcomes
- Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time(Weeks 4, 12, 24, 36, 48, 60, and 84)
- Number of Participants With Normal Serum Alanine Transaminase Levels Over Time(Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, and 84)
- Mean Score of Beck Depression Inventory Over Time(Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84)
- Mean Score of Fatigue Severity Over Time(Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84)
- Number of Participants With Serious Adverse Events and Adverse Events(Up to Week 84)
- Number of Participants With Individual Flu-like Symptom(Baseline (Week 0); Weeks 12, 36, 60 and 84)
- Number of Participants With Marked Laboratory Abnormalities(Up to Week 84)
- Number of Participants With Abnormal Vital Signs(From screening (Day -21 to Day -1) to Week 84)
- Mean Score for Overall Local Injection Site Reaction(Baseline (Week 0), Week 4, 12, 24, 36, 48 and 60)