EUCTR2007-004993-15-BE进行中（未招募）1 期
A Randomized, Open-Label, Multicenter Study Examining the Effects of 24 Versus 48 Weeks of Combination Therapy with PEGASYS® (Peginterferon alfa-2a 40KD) plus COPEGUS® (Ribavirin) on Sustained Virological Response in Patients with Chronic Hepatitis C, Genotype 2 or 3 who do not Achieve a Rapid Viral Response - NCORE 2/3
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients greater than or equal to 18 years of age at treatment initiation
- •Serologic evidence of chronic hepatitis C (CHC) infection by an anti-HCV antibody test prior to therapy
- •Patients with CHC genotype 2 or 3
- •Patients in whom therapy with PEGASYS® plus COPEGUS® was initiated at the discretion of the investigator according to local standard of care with PEGASYS® 180µg/week plus COPEGUS® 800 mg/d or 1000/1200 mg/d adhering to the sections: Contraindications” and Special Warnings and Precautions” of the current summaries of product characteristics (SPCs) / US Product Information (USPI) / local labeling (Please refer to the Investigator’s Folder for local labeling).
- •Quantifiable Serum HCV RNA >43 IU/mL by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test within 3 months prior to treatment initiation with PEGASYS® plus COPEGUS®
- •Detectable Serum HCV RNA by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after 4 weeks of treatment with PEGASYS® plus COPEGUS® (i.e. 21 to 35 days after start of treatment)
- •Information on PEGASYS® and COPEGUS® compliance including dose modifications and treatment interruptions during the first 6-8 weeks of treatment have to be available and are documented in the patient chart
- •Patient must be able to comply with the adherence assessments during the study
- •Compensated liver disease (Child-Pugh Grade A clinical classification for patients with cirrhosis: total score less than or equal to 6)
- •Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug (i.e. treatment week 6-8)
- •All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment with study drugs and 6 months post treatment completion
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria at Study Entry (treatment week 6-8)
- •Women with ongoing pregnancy or breast feeding
- •Male partners of women who are pregnant
- •Patients with CHC genotype 1
- •Pegylated interferon, standard interferon or ribavirin therapy at any time prior to
- •initiation of the current therapy with PEGASYS® plus COPEGUS®
- •Any investigational drug within less than or equal to 6 weeks prior to the first dose
- •of the current therapy with PEGASYS® plus COPEGUS®
- •Co-infection with hepatitis A, hepatitis B or human immunodeficiency virus (HIV)
- •History or other evidence of decompensated liver disease (Coagulopathy,
- •hyperbilirubinemia, hepatic encephalopathy, hypo-albuminemia, ascites, and
- •bleeding from esophageal varices are conditions consistent with
- •decompensated liver disease)
- •Signs or symptoms of hepatocellular carcinoma
- •Not adequately controlled thyroid dysfunction, diabetes mellitus or psychiatric
- •Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or
- •clinically relevant ophthalmological disorder (e.g. due to diabetes mellitus or
- •hypertension)
- •Any form of substance abuse (including excessive alcohol consumption) that
- •precludes successful participation in the study at the discretion of the investigator
- •Inability or unwillingness to provide written informed consent or abide by the
- •requirements of the study
- •Exclusion Criteria at Randomization (treatment week 24):
- •Patients who did NOT achieve an early virological response at week 12 (EVR
- •defined as undetectable HCV RNA or a drop of =2-log10 measured 71 to 98 days
- •after start of treatment)
- •Neutrophil count <500 cells/mm3 or platelet count <25,000 cells/mm3 or
- •hemoglobin <8.5 g/dL
- •Patients who discontinued study medication
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