Multicentre, Randomised, Open-label Study Comparing the Tolerability and Viral Reduction of the Combination of IFN Alpha-2b XL + Ribavirin Versus Peg IFN Alpha-2b + Ribavirin in Patients With Chronic Hepatitis C, Genotype 1 or 4.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Viral load decrease at Week 4 and Week 12 of treatment with IFN alfa-2b XL 27 MIU, IFN alfa-2b XL 36 MIU and the marketed reference product (PEG IFN alfa-2b 1.5μg/kg) in combination with ribavirin
研究概览
简要总结
Three-parallel-arm, open-label, international (France and Romania) study, comparing three treatments
The purpose of this study is to confirm if IFN alfa-2b XL has a better antiviral activity and tolerability as compared with current marketed reference, while combined with ribavirin, in a 3-month therapy setting.
详细描述
Interferon alfa-2b XL (IFN alfa-2b XL) is a novel sustained release interferon α-2b drug product that is being developed by FLAMEL TECHNOLOGIES using its Medusa® technology, aiming at reducing the toxicity and enhancing the biological response. In the present study, patients will be randomly assigned to either IFN alfa-2b XL 27 MUI, IFN alfa-2b XL 36 MUI, or IFN peg alfa-2b 1.5 µg/kg, all administered once a week for 12 weeks by subcutaneous injections, in combination with weight dosed ribavirin daily administered orally in two divided doses. Doses will be adapted according to the dose modification guidelines for combination therapy labelled in the ribavirin prescribing information.
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
- •Patient having voluntarily signed the Informed Consent Form prior to any study specific procedure being performed
- •Male or female HCV genotype 1 or 4 infected patients (positive serum HCV RNA), aged between 18 and 65 years inclusive, with a body mass within the range over or equal of 45Kg and below or equal to 100 Kg
- •Patient being either naïve to therapy, either non-responder to previous standard Peg-interferon α + ribavirin therapy,
- •With no absolute contra-indication to interferon α or ribavirin
- •Female patients must be non-lactating and of non-childbearing potential, or have a negative pregnancy test results to enter the study
- •No evidence of acute or advanced liver disease, uncontrolled diabetes, cardiovascular, immunological, or thyroid disease, and no recently diagnosed malignancy
- •Vital signs within normal ranges, or if outside the normal ranges, not deemed clinically significant in the opinion of the Investigator. An ECG with no clinically significant abnormalities
排除标准
- •History of solid organ transplantation
- •Severe systemic infection, uncontrolled diabetes, cancers, associated liver disease
- •General anesthesia or recent blood transfusion
研究组 & 干预措施
GP3N IFN peg alfa-2b 1.5 µg/kg + Ribavirin
IFN peg alfa-2b 1.5 µg/kg,administered once a week for 12 weeks by subcutaneous injections
干预措施: IFN peg alfa-2b 1.5 µg/kg + Ribavirin (Drug)
GP1N IFN alfa-2bXL 27 MUI + Ribavirin
IFN alfa-2bXL 27 MUI, powder and solvent for solution injection
干预措施: IFN alfa-2b XL 27 MUI + Ribavirin (Drug)
GP2N IFN alfa-2b XL 36 MUI + Ribavirin
IFN alfa-2b XL 36 MUI, powder and solvent for solution injection
干预措施: IFN alfa-2b XL 36 MUI + Ribavirin (Drug)
结局指标
主要结局
Viral load decrease at Week 4 and Week 12 of treatment with IFN alfa-2b XL 27 MIU, IFN alfa-2b XL 36 MIU and the marketed reference product (PEG IFN alfa-2b 1.5μg/kg) in combination with ribavirin
时间窗: Week 4 and Week 12
次要结局
- Percentage of patients with complete early virologic response (EVR) (viral load <15 IU) at the end of the week 12(Week 4 and Week 12)
- Percentage of patients with early virologic response (EVR) (reduction of at least 2 log viral load) at the end of week 12(Week 4 and Week 12)