An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Effectiveness of 36 vs 48 Wks PegIntron Plus Ribavirin Treatment for HCV Patients Without Rapid Virologic Response(RVR) But With Undetectable HCV RNA at wk 8
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- The rate of sustained virologic response
研究概览
简要总结
Purpose:
To compare the effectiveness of 36 weeks versus 48 weeks pegintron plus ribavirin treatment for hepatitis C virus(HCV) patients without rapid virologic response(RVR), but with undetectable HCV RNA at wk 8.
Study Design:
a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV Genotype 1 patients who fail to achieve RVR but achieve undetectable HCV RNA at week 8 (<50 IU/ml) will be recruited into 2 arms(30 in each arm). Patients must receive pegylated interferon-α2b at 1.5 μg/kg of body weight/week and ribavirin 800~1400 mg/day for 12 wks before entering this study.
详细描述
Purpose:
To compare the effectiveness of 36 wks versus 48 wks pegintron plus ribavirin treatment for HCV patients without RVR, but with undetectable HCV RNA at wk 8.
Study Design:
This is a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV Genotype 1 patients who fail to achieve RVR at wk 4 but achieve undetectable HCV RNA at wk 8 (<50 IU/ml) will be recruited into 2 arms(30 in each arm). Patients must receive pegylated IFN-α2b at 1.5 μg/kg of body weight/week and ribavirin 800~1400 mg/day for 12 wks before entering this study.
Study Duration:
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
- None
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
- •Aged 20y/o or older
- •Positive for the HCV antibody and HCV RNA detected with abnormal ALT (≧ 1X) before initiating PegIFN plus RBV treatment
- •HCV Genotype 1
- •Have failed to achieve RVR at week 4 but achieve undetectable HCV RNA at week 8 (< 50 IU/ml) with PegIFN plus RBV treatment
- •Have received PegIFN plus RBV treatment for 12weeks with good compliance (who have received >80% of expected PegIFN and RBV doses and completed at least 80% of the expected duration (80/80/80 adherence) and achieve EVR before entering this study
排除标准
- •Subjects with decompensated liver disease or overt cirrhosis by ultrasound.
- •With prior exposures to interferon (standard or pegylated) treatment before baseline.
- •With human immunodeficiency virus
- •With hepatitis B infection
- •With neutrophil count < 1500 mm3,
- •With platelet count < 90000 mm3,
- •With hemoglobin level < 12g/dL for men or < 11 g/dL for women
- •With serum creatinine level > 1.5 mg/dL
- •With clinically significant cardiac or cardiovascular abnormalities, organ grafts, systemic infections, clinically significant bleeding disorders, evidence of malignant neoplastic diseases
- •Female patients with pregnancy or lactation. Pregnancy in partners of male patients.
- •Hypersensitive to study drugs cases.
研究组 & 干预措施
Pegintron + Riba for 36 wks in total
Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800~1400 mg/day for 24 weeks (36 weeks in total HCV treatment)
干预措施: Pegintron + Riba (Drug)
Pegintron + Riba for 48 wks in total
Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800~1400 mg/day for 36 weeks (48 weeks in total HCV treatment)
干预措施: Pegintron + Riba (Drug)
结局指标
主要结局
The rate of sustained virologic response
时间窗: At 24 weeks after end of treatment
The comparison of the rates of sustained virologic response (SVR) defined as the proportion of patients with loss of serum HCV RNA at week 24 of post-treatment between patient groups (36 vs 48 weeks of treatment period)
次要结局
- the factors associated with sustained virologic response(SVR) between groups(24 weeks after the end of treatment)
- the rate of end-of-treatment response(EOT)(At the end of treatment (36 or 48 weeks of treatment period))
- The relapse rate(At 24 weeks after end of treatment)