A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Early Virologic Response
研究概览
简要总结
Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk for acquiring hepatitis C. The investigators are trying the PEGASYS (Peginterferon alpha-2a(40 KD)) plus Ribavirin in Thalassemic patients with HCV.
详细描述
Patients with Thalassemia receive chronic blood transfusions and have an increased prevalence of chronic Hepatitis C virus (HCV) infection, particularly if transfused before HCV serological testing became available. The investigators enrolled 300 patients into the study. The patients received PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 1000 milligram for weight less than or equal 75 kg and 1200 milligram for more than 75 kg for 48 weeks. Follow up period is 6 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the third months 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
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV RNA positive
- •Age older than 12 years
排除标准
- •Ongoing pregnancy or breast feeding
- •History (Hx) of Hepatocellular Carcinoma (HCC)
- •Hx of alcoholic liver disease
- •Hx of bleeding from esophageal varices
- •Hx of hemochromatosis
- •Hx of autoimmune hepatitis
- •Hx of Suicidal attempt
- •Hx of cerebrovascular dis
- •Hx of severe retinopathy
- •Hx of severe psoriasis
- •Hx of scleroderma
- •Hx of metabolic liver disease
- •Hx of Systemic Lupus Erythematosus (SLE)
研究组 & 干预措施
1
Thalassemic Patients with HCV
干预措施: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) (Drug)
结局指标
主要结局
Early Virologic Response
时间窗: After 12 weeks of Treatment
End of Treatment Response
时间窗: 48 Weeks
Sustained Virologic Response
时间窗: 24 weeks after Treatment
Rapid Virologic Response
时间窗: One month after Treatment
次要结局
- Tolerability of drugs for whole therapy period(During Treatment)
- Biochemical response (ALT)(End of Treatment AND 24 weeks after Treatment)
- Laboratory Parameters(During Treatment AND End of treatment)