Tolerability and User Handling Study of an Autoinjector to Administer 180 µg/0.5 mL Peginterferon Alfa-2a (Pegasys, PEG-IFN)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
研究概览
简要总结
This randomized, cross-over, open label study will compare the tolerability and handling of application of peginterferon alfa-2a [Pegasys] by autoinjector versus pre-filled syringe in patients with chronic hepatitis C, either on treatment with peginterferon alfa-2a for at least 12 weeks or treatment-naïve for peginterferon alfa-2a. Patients will be randomized to self-injection of 180mcg peginterferon alfa-2a once a week using either an autoinjector or a prefilled syringe for 3 weeks, then switch to use the other method of injection for another 3 weeks. Anticipated time on study treatment is 6 weeks. Target sample size is <100 patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >/=18 years of age
- •chronic hepatitis C
- •on treatment with peginterferon alfa-2a for >/= 12 weeks at baseline, or treatment-naïve for peginterferon alfa-2a
排除标准
- •history or evidence of decompensated liver disease
- •autoimmune hepatitis
- •hypersensitivity to peginterferon alfa-2a or any of its components
- •concomitant treatment that requires administration by self-injection, or prior use of an autoinjector
结局指标
主要结局
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
时间窗: Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)
The feasibility of PEG-INF administration by AI was assessed by Injection Method Observational Survey questions, based on following pre-defined questions using a "Yes" or "No" response: 1) Did the participant exhibit any nervousness prior to the injection? 2) Did the participant exhibit any difficulty initiating the injection? 3) Did the participant appear confident performing the injection? 4) Did the participant follow the instructions for performing the injection without the need for additional instructions or guidance? 5) Did the participant experience any technical problems with the device or syringe during the injection? 6) Did the participant withdraw the device/syringe before the injection was complete? 7) Did the participant exhibit any visible pain or physical discomfort? 8) Did the participant appear to be satisfied using the device or syringe? 9) Did the participant exhibit any frustration using the syringe or device?
次要结局
- Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein(Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days))
- Number of Participants With Marked Laboratory Abnormalities in Creatinine(Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days))
- Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure(Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days))
- Number of Participants With Marked Laboratory Abnormalities in Hematocrit(Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days))
- Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil(Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days))
- Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC)(Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days))
- Number of Participants With Marked Laboratory Abnormalities in Prothrombin Time (PT) International Normalized Ratio (INR)(Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days))
- Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase(Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days))
- Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose(Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days))
- Number of Participants With Abnormalities in Electrocardiograms(Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days))
- Number of Participants With Adverse Events (AE)(Upto Day 36)