A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C
- Conditions
- Chronic Hepatitis C
- Registration Number
- NCT00144469
- Lead Sponsor
- Chugai Pharmaceutical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).
- Secondary Outcome Measures
Name Time Method Biochemical response (normalization of serum alanine aminotransferase activity), Virological response (HCV-RNA <50IU per milliliter) at the end of therapy.