Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- End of treatment response rate (HCV RNA:Neg)
研究概览
简要总结
Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a (Pegaferon®) in the patients with chronic hepatitis C.
详细描述
We enroll 50 patients in to the study. The patients receive Pegaferon® 180 micgr per week plus ribavirin 10-15mg/kg per day. The patients are visited every 4 weeks with biochemistry lab tests. They are checked with quantitative HCV PCR on the third month after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV RNA: Positive
- •Biopsy approved in genotype 1
- •Age older than 18 yrs
排除标准
- •ongoing pregnancy or breast feeding
- •Hx of hemochromatosis
- •Hx of metabolic liver dis.
- •Hx of HCC
- •Hx of autoimmune hepatitis
- •Hx of alcoholic liver dis.
- •Hx of bleeding from esophageal varices
- •ongoing systemic anti-viral or anti-neoplasmic treatment
- •Hx of treatment with an anti-depressant medication at therapeutic doses for at least 3 months at any pervious time
- •Hx of treatment with an tranquilizer at therapeutic doses for psychosis for at least 3 months at any pervious time
- •Hx of hospitalization for psychiatric dis.
- •Hx of suicidal attempt
- •Hx of IBD
- •Hx of SLE
- •Hx of scleroderma
- •Hx of rheumatoid arthritis
- •Hx of ITP
- •Hx of autoimmune hemolytic anemia
- •Hx of severe psoriasis
- •Hx of chronic pulmonary dis. associated with functional limitation
- •Hx of MI or unstable angina
- •Hx of arrhythmia requiring ongoing treatment
- •Hx of functional class III or IV
- •Hx of severe seizure dis. or current anti-convulsant use
- •Hx of organ transplantation with existing functional graft
- •Hx of severe retinopathy
- •Hx of Thalassemia
- •Hx of spherocytosis
- •Hx of cerebrovascular dis.
结局指标
主要结局
End of treatment response rate (HCV RNA:Neg)
时间窗: End of treatment course
次要结局
- Sustain response rate (HCV RNA:Neg) 6 month after end of treatment(6 month after end of treatment)