A Phase III Study of Ro25-8310 (Peginterferon Alfa-2a) in Combination With Ro20-9963 (Ribavirin) in Patients With Chronic Hepatitis C
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).
次要结局
- Biochemical response (normalization of serum alanine aminotransferase activity),
- Virological response (HCV-RNA <50IU per milliliter) at the end of therapy.