An Open Label Study of a Fixed Dose Regimen of MabThera on Overall Response Rate in Patients With Refractory, Relapsing or Chronic Idiopathic Thrombocytopenic Purpura.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR)
研究概览
简要总结
This single arm study will evaluate the efficacy and safety of MabThera monotherapy in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP). Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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;
- •refractory, relapsing or chronic idiopathic thrombocytopenic purpura;
- •stable therapy during 3 weeks prior to study entry.
排除标准
- •newly diagnosed ITP (<6 weeks);
- •prior treatment with MabThera;
- •active bleeding requiring platelet transfusion within 7 days prior to entry into study.
研究组 & 干预措施
1
干预措施: rituximab [MabThera/Rituxan] (Drug)
结局指标
主要结局
Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR)
时间窗: Week 8
Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (\>) 150x10\^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of \>50x10\^9/L over at least 2 consecutive measurements at least \<2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs.
次要结局
- Cluster of Differentiation 19 (CD19) B Cell Count(Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day)
- Percentage of Participants Who Achieved CR(Week 52)
- Percentage of Participants Who Achieved PR(Week 52)
- Percentage of Participants With Continued CR From Week 8 to Week 52(Week 8 to Week 52)
- Duration of CR in Participants With Continued CR From Week 8 Until Week 52(Week 8 to Week 52)
- Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event(Week 52)
- Time to CR(Baseline to Week 52)
- Time to PR(Baseline to Week 52)
- Percentage of Participants Who Achieved MR(Week 52)
- Percentage of Participants With a Therapeutic Response(Week 26 and Week 52)
- Change From Baseline in CD19 B Cell Count(Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day)
- Duration of MR in Participants With Continued MR From Week 8 Until Week 52(Week 8 to Week 52)
- Percentage of Participants With Hematological CR, PR, or Minor Response (MR)(Week 8)
- Percentage of Therapeutic Responders(Week 26 and Week 52)
- Duration of PR in Participants With Continued PR From Week 8 Until Week 52(Week 8 to Week 52)
- Time to Initiation of New ITP Therapy(Baseline to Week 52)
- Time to MR(Baseline to Week 52)