NCT01609452撤回2 期
MONICA-SC: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With Immune Thrombocytopenic Purpura (ITP)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment.
研究概览
简要总结
The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when administered on top of standard-of-care to subjects with Immune Thrombocytopenic Purpura (ITP).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years of age(male or female).
- •Diagnosis of ITP according to the guidelines of the American Society of Hematology (ASH) and British Committee for Standards in Hematology.
- •Platelet counts at Screening of 30 billion/L or less for subjects not on ITP medication, or 50 billion/L or less for subjects receiving stable background ITP medication.
排除标准
- •Subjects who have had a splenectomy for any reason.
- •Currently receiving high-dose ITP medications, eltrombopag, romiplostim, rituximab, or investigational therapeutic agents.
- •Nursing or pregnant.
- •Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days.
- •Any known history of bone marrow stem cell disorder.
- •Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C.
- •Liver disease.
- •Malignancy within the past 5 years.
- •History of active tuberculosis (TB) or history of TB infection.
- •Subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study.
- •History of congenital immunodeficiency.
结局指标
主要结局
Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment.
时间窗: 24 weeks
次要结局
- Biomarker changes from baseline.(baseline to 24 weeks)
- Change in background corticosteroid dose.(baseline to 24 weeks)
- Time to treatment failure.(24 weeks)
- Change in bleeding risk.(baseline to 24 weeks)
- Achievement of a durable platelet count of 50 billion platelets per liter or higher over the last weeks of treatment under conditions of decreased concomitant steroid medication.(24 weeks)
- Achievement of a transient improvement in platelet count of 50 billion platelets per liter or higher at any 4 weeks of the treatment period.(24 weeks)
- Percentage of subjects requiring rescue therapy.(24 weeks)
- Safety profile (AEs, vitals signs, labs)(24 weeks)
研究者
相似试验
撤回
2 期
BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel VasculitisGranulomatosis With PolyangiitisMicroscopic PolyangiitisNCT01598857Anthera Pharmaceuticals
终止
3 期
CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without NephritisSystemic Lupus ErythematosusNCT02514967Anthera Pharmaceuticals3
撤回
3 期
CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without NephritisSystemic Lupus ErythematosusNCT02074020Anthera Pharmaceuticals
已完成
2 期
BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous AdministrationIgA NephropathyNCT02062684Anthera Pharmaceuticals57
已完成
3 期
CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT01395745Anthera Pharmaceuticals442