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

Phase 1

• Conditions: Immune thrombocytopenic purpura (ITP)

• Registration Number: EUCTR2005-005918-20-SE
• Lead Sponsor: Sykehuset Østfold, Fredrikstad

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-04
• Study Completion: 2013-01-15
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified