Pharmacokinetics and Pharmacodynamics of Intravenous Administration of Pegylated Interferon-2a in Patients With Chronic Hepatitis C and Previous Non-response to Standard Combination Therapy With Pegylated Interferon and Ribavirin (Intervention Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- HCV RNA levels (IU/ml, COBAS TaqMan HCV Test) in correlation with area under the plasma concentration-time curve (AUC) after sc and iv administration
研究概览
简要总结
In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with viral load and viral kinetics will be investigated in patients with chronic hepatitis C genotype 1 who were non-responders to previous standard combination therapy with pegylated interferon and ribavirin. Patients will be randomized to receive either weekly or twice weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after a washout period of 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult caucasian patients, 18 - 70 years of age
- •Hepatitis C, genotype 1
- •Non-responder to previous anti-HCV therapy with peginterferon alfa and ribavirin
- •Compensated liver disease (Child-Pugh class A) for >/= 24 months before baseline
- •Positive for anti-HCV for > 6 months, with detectable serum HCV-RNA
排除标准
- •Treatment-naïve or responder to previous therapy
- •HCV infection other than genotype 1
- •Positive for Hepatitis A, Hepatitis B or HIV infection at screening
- •Chronic Hepatitis of other than HCV origin
- •Decompensated liver disease (Child-Pugh class B or C)
- •Therapy with systemic antiviral, antineoplastic or immunomodulatory agents in the 6 months prior to study
- •Clinically relevant retina disorder
- •Pregnant or lactating women and male partners of pregnant women
研究组 & 干预措施
A/B
干预措施: peginterferon alfa 2a [Pegasys] (Drug)
A/B
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
C/D
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
HCV RNA levels (IU/ml, COBAS TaqMan HCV Test) in correlation with area under the plasma concentration-time curve (AUC) after sc and iv administration
时间窗: 11 months
次要结局
- Effect of waist to hip ratio on viral response(11 months)
- Effect of waist to hip ratio on pharmacokinetics(11 months)
- Evaluation of predictors of response to i.v. treatment(11 months)
- Incidence of adverse events(11 months)