PATIENTS WITH AUTOIMMUNE THROMBOCYTOPENIA. MedDRA version: 8.1 Level: LLT Classification code 10050245 Term: Autoimmune thrombocytopenia
Conditions
Interventions
Trade Name: MABTHERA
Pharmaceutical Form: Concentrate for solution for infusion
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
UNIVERSITA DEGLI STUDI DI UDINE
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: AUTOIMMUNE THROMBOCYTOPENIA NEVER TREATED BEFORE; PREGNANCY AND NURSING;HIV, HBV AND HCV POSITIVITY; OTHER SEVERE CONCOMITANTE PATHOLOGIES.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed