A Phase III Study of Ro25-8310 (Peginterferon Alfa-2a) in Combination With Ro20-9963 (Ribavirin) in Patients With Chronic Hepatitis C
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Chugai Pharmaceutical
- Enrollment
- 300
- Primary Endpoint
- Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).
Study Overview
Brief Summary
This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with peginterferon alfa-2a monotherapy.
Additionally, the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy.
Detailed Description
Treatment-naïve patients were randomly assigned in a 1:1 ratio to 48 weeks of double-blind treatment with subcutaneous, once-weekly injections of 180 μg of peginterferon alfa-2a (40KD) plus either twice-daily oral ribavirin (600 to 1000mg/day) or placebo.
All patients who had received previous treatment with conventional interferon but had failed to respond (no suppression of HCV-RNA below detection limits of a sensitive assay) or had relapsed (reversion to HCV-RNA positive state after suppression) received the combination of peginterferon alfa-2a (40KD) plus ribavirin for 48 weeks at the dosages stated above.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients with quantifiable serum HCV-RNA (≥500 IU/mL))
- •elevated serum alanine aminotransferase activity (≥45 IU per liter)within six months of screening
- •liver biopsy findings consistent with a diagnosis of chronic hepatitis C.
Exclusion Criteria
- •Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
- •leukopenia (fewer than 3,000 white blood cells per cubic millimeter)
- •thrombocytopenia (fewer than 90,000 platelets per cubic millimeter)
- •anemia (less than 12 g hemoglobin per deciliter )
- •hepatitis B co-infection
- •decompensated liver disease
- •organ transplant
- •creatinine clearance less than 50 milliliters per minute
- •poorly controlled psychiatric disease
- •poorly controlled diabetes
- •malignant neoplastic disease
- •severe cardiac or chronic pulmonary disease
- •immunologically mediated disease
- •retinopathy.
Outcomes
Primary Outcomes
Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).
Secondary Outcomes
- Biochemical response (normalization of serum alanine aminotransferase activity),
- Virological response (HCV-RNA <50IU per milliliter) at the end of therapy.