OW DOSE RITUXIMAB IN THE TREATMENT OF AUTOIMMUNE THROMBOCYTOPENIA. - ND
- Conditions
- PATIENTS WITH AUTOIMMUNE THROMBOCYTOPENIA.MedDRA version: 8.1Level: LLTClassification code 10050245Term: Autoimmune thrombocytopenia
- Registration Number
- EUCTR2006-005011-10-IT
- Lead Sponsor
- IVERSITA DEGLI STUDI DI UDINE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
AGE OR 16 YEARS OLD; REFRACTORY OR RELAPSED AUTOIMMUNE THROMBOCYTOPENIA; WRITTEN INFORMED CONSENCE.
Are the trial subjects under 18? yes
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
AUTOIMMUNE THROMBOCYTOPENIA NEVER TREATED BEFORE; PREGNANCY AND NURSING;HIV, HBV AND HCV POSITIVITY; OTHER SEVERE CONCOMITANTE PATHOLOGIES.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: OVERALL AND COMPLETE RESPONSES.;Secondary Objective: GRADE AND DURATION OF B-DEPLETION AND TREND OF IMMUNOGLOBULINES; DURATION OF RESPONSE; RITUXIMAB PHARMACOCYNETIC; COMPARISON WITH HISTORICAL DATAS; TOXICITY OF RITUXIMAB.;Primary end point(s): SALVAGE TREATEMENT OF PATIENTS WITH AUTOIMMUNE THROMBOCYTOPENIA ALREADY TREATED WITH AT LEAST ONE LINE OF THERAPY AND RESULTED REFRACTORY OR RELAPSED.
- Secondary Outcome Measures
Name Time Method