NCT00519792已完成1 期
Phase Ib Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Omega DUROS® and Ribavirin in Subjects With Chronic Hepatitis C Previously Treated With Pegylated Interferon and Ribavirin
Intarcia Therapeutics8 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Safety
研究概览
简要总结
Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days.
This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with chronic Hepatitis C genotype 1.
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
- •Chronic Hepatitis C with HCV genotype 1 infection
- •Relapse following an end of treatment response after treatment with a pegylated interferon and ribavirin.
排除标准
- •Presence or history of non-HCV chronic liver disease
- •Treatment with any interferon subsequent to the relapse with pegylated interferon-alpha and ribavirin
- •Decompensated liver disease
研究组 & 干预措施
1
Experimental
Omega DUROS: Dose 25
干预措施: Omega DUROS device (Drug)
2
Experimental
Omega DUROS: Dose 50
干预措施: Omega DUROS device (Drug)
结局指标
主要结局
Safety
时间窗: Week 52
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
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