R-ITP: Clinical Evaluation of Rituximab in Primary Immune Thrombocytopenia

Phase 3

Completed

• Conditions: Idiopathic Thrombocytopenic Purpura

• Registration Number: JPRN-jRCT1091220070
• Lead Sponsor: Keio University School of Medicine , Yoshitaka miyakawa

Brief Summary

We demonstrated the efficacy and safety of rituximab in Japanese patients with chronic ITP. The response rate was similar to that in previous reports in the US and Europe. We plan to propose that the Japanese government approve chronic ITP as a new indication for rituximab.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-12
• Study Completion: 2013-10-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1)Diagnosis of ITP according to guidelines (The Study Group for Intractable Hematopoietic Diseases supported by the Ministry of Health and Welfare, Japan. 1991) at least 12 months before entry
2)A platelet count <=30,000/micro L(week -4,-2 before inclusion)
3)ECOG performance status 0-2
4)Patients>=20 years old
5)Patient who was ineffective or intolerable for steroid
6)Patient who was ineffective or judged as being inappropriate for splenectomy by investigators
7)Patient who was ineffective or intolerable or judged as being inappropriate by investigators for thrombopoietin-receptor
8)Hemoglobin>=10g/dL
9)Creatinine<=2mg/dL
10)Total bilirubin smaller than 1.5 X upper limit of normal,ALT and AST smaller than 3 X upper limit of normal
11)Written informed consent

Exclusion Criteria

1)Patients with past medical history of allergy to Rituximab
2)Patients with serious somatic symptom(excluding ITP)
3)Patients with alcoholism within 1 years
4)Patients with suspected blood disorder (excluding ITP)
5)Patients with suspected cyclic thrombocytopenia
6)HIV, HCV,HBc antibody or HBs antigen positivity
7)Patients with no active malignancy or history
8)Patients being treated for TIP at study entry(excluding Patients who have taken steroid,azathioprine,danazol,cyclosporin or mycophenolate mofetil during a certain period of time prior to the study entry.)
9)Patients who have taken platelet transfusion,immunoglobulin therapy ,splenectomy, steroid,and so on drugs within a certain period of time prior to the study entry.
10)Patients who have taken antineoplastic within 8 weeks prior to study entry
11)Patients who have taken antibody drugs
12)Females who are pregnant or desire childbearing.
13)Patients judged as being inappropriate for this study by investigators
14)Patients under other clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified