NCT00304551已完成3 期
A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])
研究概览
简要总结
This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC.
Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 to 75 years-old with quantifiable serum HCV-RNA (≥ 500 IU/mL), elevated serum alanine aminotransferase activity (≥ 45 IU per liter) within sixty days of screening, and proven CHC with compensated LC (Child-Pugh A) on liver biopsy.
排除标准
- •Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
- •Thrombocytopenia (fewer than 75,000 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
研究组 & 干预措施
2
Experimental
干预措施: peginterferon alfa-2a 90μg (Drug)
2
Experimental
干预措施: ribavirin (Drug)
1
Experimental
干预措施: peginterferon alfa-2a 180μg (Drug)
1
Experimental
干预措施: ribavirin (Drug)
结局指标
主要结局
Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])
时间窗: week 24 from the end of treatment
次要结局
- Biochemical response (normalization of serum alanine aminotransferase activity)(at the end of treatment and week 24 form the end of treatment)
- Virological response (HCV-RNA < 50 IU per milliliter)(at the end of treatment and week 24 form the end of treatment)
研究者
研究点 (8)
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