Rituximab as second line treatment for ITP. A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study. - RITP study

Sykehuset Østfold, Fredrikstad0 个研究点目标入组 20 人开始时间: 2009年3月4日最近更新: 2022年4月19日

试验速览

暂无简介。

•Inclusion criteria (for randomisation):
•1. ITP with platelet count 10 - 30 x 109/l after 2 weeks of treatment with prednisolon or during prednisolon tapering period i.e. from week three of prednisolon initiation. Patients with platelet count between 30 -50 are eligible if a higher platelet count is considered necessary, because of : concomitant medical illness predisposing to bleeding (hypertension, GI bleeding, bleeding diathesis, previous history of bleeding) concomitant medical condition requiring platelet blocking agents/ anticoagulation, persistent bleeding despite platelets > 30 x 109 /l, prior to surgery, or because of other patient related factors necessitating higher platelet count as occupation, hobby, psychological intolerability.
•2. Subject is >18 years
•3. Subject has signed and dated written informed consent.
•4. Subject is able to understand and comply with protocol requirements and instructions, and intends to complete the study as planned.
•5. Females in fertile age should express willingness for use of contraceptive means for 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

•1. Previous treatment with splenectomy, chemotherapy, anti-D Ig, Rituximab, or immune-suppressive treatments other than corticosteroids.
•2. Presence of malignant haematological disease
•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. Not willing to use contraception for 6 month.

发起方

Sykehuset Østfold, Fredrikstad