A Double-Blind, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of Romiplostim, Administered Once Weekly to Thrombocytopenic Hepatitis C (HCV) Infected Subjects Who Are Not Candidates for Antiviral Treatment With Pegylated Interferon and Ribavirin Due to Persistent Thrombocytopenia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Mean platelet count for actively treated and placebo treated subjects
研究概览
简要总结
RATIONALE: Romiplostim may cause the body to make platelets.
PURPOSE: This randomized phase II trial is studying how well romiplostim works in treating hepatitis C-infected patients with thrombocytopenia.
详细描述
PRIMARY OBJECTIVES:
I. To assess the platelet count response to administration of weekly romiplostim patients with HCV infection whose initial platelet count is < 70,000/L.
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of romiplostim the treatment of patients with HCV infection and thrombocytopenia; including physical symptoms and findings, hematologic, serum chemistries and liver function tests and adverse events.
II. To assess the ability of romiplostim to enable subjects to achieve a platelet count sufficient to start antiviral therapy.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: romiplostim (Biological)
Arm I
Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: ribavirin (Drug)
Arm I
Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: PEG-interferon alfa-2a (Biological)
Arm I
Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Arm II
Patients receive placebo subcutaneously once weekly for 8 weeks. Patients failing to achieve a platelet count of > 100,000/L cross over to arm I.
干预措施: ribavirin (Drug)
Arm II
Patients receive placebo subcutaneously once weekly for 8 weeks. Patients failing to achieve a platelet count of > 100,000/L cross over to arm I.
干预措施: placebo (Other)
Arm II
Patients receive placebo subcutaneously once weekly for 8 weeks. Patients failing to achieve a platelet count of > 100,000/L cross over to arm I.
干预措施: PEG-interferon alfa-2a (Biological)
Arm II
Patients receive placebo subcutaneously once weekly for 8 weeks. Patients failing to achieve a platelet count of > 100,000/L cross over to arm I.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Mean platelet count for actively treated and placebo treated subjects
时间窗: Weeks 6-8
次要结局
- Incidence of adverse events, including clinically significant changes in laboratory values and the incidence of antibody formation(Weeks 1-24)
- Number of subjects in each treatment group who achieve a platelet count of greater or equal to 100,000/L(Week 8)
- Number of patients originally receiving active treatment who maintain a platelet count > 50,000/L while receiving anti-viral therapy with pegylated interferon and ribavirin(Weeks 9-24)
- Changes in plasma HCV viral load during treatment with romiplostim alone(Weeks 1-8)
- Incidence of sustained viral response achieved during treatment with anti-viral therapy in combination with romiplostim(Weeks 9-24)