EUCTR2005-005918-20-GB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” - The RITP study” Protocol version 5
Rikshospitalet0 个研究点目标入组 110 人开始时间: 2010年10月29日最近更新:
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
入选标准
- •1. ITP with platelet count <30 x 109 /l or 30-50 x 109 /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 109 /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 109 /l) or relapse (Platelet count falls to < 30 x 109 /l) during the dose tapering period or after discontinuation of corticosteroids.
- •3. Subject is >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?
- •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)
- •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) (> 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
- •11. Bacterial infections, viral infections, fungal infections, myco-bacterial
- •infections (excluding ungeal fungal infections) or other evolutive infections or
- •any other infections episode requiring hospitalisation or treatment with an antibiotics 4 weeks before selection for IV route or within 2 weeks before selection for oral route.
- •12. History of soft tissue, bone or joint infections (fascitis, abscess, osteomyelitis, septic arthritis) during the last year prior to inclusion in the study.
- •13. Medical history of relapsing or chronic severe infectious diseases or any other
- •underlying pathology predisposing to serious infections.
- •14. Known Primary or secondary immune deficiency syndromes.
- •15. Administration of a living vaccine within 4 weeks preceding the inclusion in
- •16. History of soft tissue, bone or joint infections (fascitis, abscess, osteomyelitis, septic arthritis) during the last year prior to inclusion in the study.
- •17. Previous treatment with inhibitors of leucocytes transmigration (e.g.:
- •18. Known intolerance to human monoclonal antibodies.
- •19. Known severe chronic pulmonary obstructive Disease (FEV < 50% or functional dyspnoea grade 3).
- •20. Known congestive heart failure NYHA (New York Heart Association classification of heart failure) class III and IV.
- •21. Recent episode (<6 months) of acute coronary syndrome.
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