EUCTR2005-005918-20-FR进行中（未招募）1 期
Rituximab as second line treatment for ITP:A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.The RITP study” - RITP study
Rikshospitalet0 个研究点目标入组 110 人开始时间: 2008年10月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria (for randomisation):
- •1. ITP with platelet count <30 x 10e9 /l or 30-50 x 10e9 /l if a higher platelet count is considered necessary because of any of the following:
- •a. Concomitant medical illness predisposing to bleeding (gastric ulcer, bleeding diathesis, previous history of bleeding).
- •b. Concomitant medical condition requiring aspirin and/or clopidogrel intake or anticoagulation.
- •c. Persistent bleeding manifestations despite platelets > 30 x 10e9 /l.
- •d. Other patient related factors necessitating higher platelet count as occupation, hobby, psychological intolerability.
- •e. Age >75 years.
- •2. Previous treatment with corticosteroids for a minimum duration of 2 weeks as recommended by the protocol (prednisone or prednisolone 1-2 mg/kg/day) with either no response (i.e. failed to achieve an initial increase in Platelet count >30 x 10e9 /l) or relapse (Platelet count falls to < 30 x 10e9 /l) during the dose tapering period or after discontinuation of corticosteroids.
- •3. Subject is > or equal = 18 years.
- •4. Subject has signed and dated written informed consent.
- •5. Subject is able to understand and comply with protocol requirements and instructions, and intends to complete the study as planned.
- •6. Females in child-bearing age should accept to use of contraceptive means for at least 6 months following the administration of the study drugs.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous splenectomy, chemotherapy, treatment with anti-D Ig, rituximab, or immune-suppressive treatments other than corticosteroids, Dapsone or Danazol.
- •2. Underlying malignancy or previous history of malignancy in the past 5 years (except skin carcinoma).
- •3. Pregnancy and lactation.
- •4. Not willing to participate in the study.
- •5. Expected survival of < 2 years.
- •6. Known intolerance to murine antibodies.
- •7. Females in child-bearing age not willing to use contraception for 6 months.
- •8. HIV/AIDS-, Hepatitis -B virus antigen positive- or Hepatitis -C virus antibodies positive- patients.
- •9. Patients with Systemic Lupus Erythematosus (SLE) (> or = 4 of the American College of Rheumatology Criteria) (Tan et al, 1982;Hochberg, 1997).
- •10. Patients currently involved in another clinical trial with evaluation of drug treatment
研究者
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