NCT00336518Unknown3 期
Efficacy and Safety of Continuing for a Total of 48 or Prolonging for a Total of 72 Weeks of Combined Treatment of Patients Receiving Pegasys and Copegus Who Are Biochemical Responders But Virological Non-Responders at Week 12 or Week 24
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment
研究概览
简要总结
Primary objective is to measure sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment
Secondary objective is to measure histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods
详细描述
Prospective, multicentre, randomized, open-label comparative study
According to our national guideline of management of patient with chronic viral hepatitis, patients need to stop therapy if they do not achieve response.
These patients can enter to the study at two time points:
- at week 16, if HCV RNS PCR measured at week 12 is positive and serum ALT > 1ULN, but decreased
- at week 28, if HCV RNS PCR measured at week 24 is still positive, but serum ALT < 2ULN.
Patients are randomized to one of the following arms:
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients above 18 and below 65 years of age chronically infected with genotype 1 HCV receiving combined Pegasys&Copegus treatment first time in-line with the valid treatment guideline approved by the National Interferon Committee (see attached guideline)
- •Subgroup 1:
- •Positive HCV PCR result at week 12 of the ongoing treatment
- •ALT > 1ULN, but the value decreased by week 12
- •Subgroup 2:
- •ALT was normal and PCR was positive at week 12, therefore combined treatment could be continued between week 12 and 24 based on the approved guideline
- •Positive HCV RNA PCR at week 24 of the ongoing treatment
- •GPT < 2 ULN at week 24 of the ongoing treatment.
排除标准
- •Women with ongoing pregnancy or breast feeding
- •Therapy with any systemic anti-neoplastic or immunomodulatory treatment at inclusion or within 6 months prior to it
- •Any investigational drug usage at inclusion or within 6 weeks prior to it
- •Co/infection with hepatitis A, B or HIV
- •Any chronic liver disease other than HCV infection
- •Sign or symptom of hepatocellular carcinoma
- •Decompensated liver disease
- •History of depression or any other relevant psychiatric disease which, in the opinion of a psychiatrist or neurologist, contraindicates study therapy
- •Uncontrolled thyroid dysfunction
- •Severe retinopathy
- •Evidence of regular alcohol consumption at inclusion or within 1 year prior to it
- •Any side effect probably caused by ongoing combined treatment which, in the opinion of the investigator, contraindicates continuation of the therapy or necessitates dose reduction of any drug in the combination therapy
- •Unwillingness to provide informed consent
- •Subgroup 1:
- •Laboratory findings at week 16 of the ongoing combined Pegasys&Copegus treatment:
- •ANC <1000/mm3
- •PLT <75.000/mm3
- •hemoglobin <10g/dl
- •creatinine >1,5 ULN
- •Subgroup 2:
- •Laboratory findings at week 28 of the ongoing combined Pegasys&Copegus treatment:
- •ANC <1000/mm3
- •PLT <75.000/mm3
- •hemoglobin <10g/dl
- •creatinine >1,5 ULN
结局指标
主要结局
Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment
次要结局
- Histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods
研究者
研究点 (2)
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