Very low doses of Rituximab for off-label treatment – a Pilot Trial - Low_Rituximab

Medical University of Vienna, Department of Internal medicine I0 sites48 target enrollmentJuly 1, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Autoimmune-haemolytic AnemiaAntiphospholipid SyndromeImmune-mediated Thrombocytopenia
Sponsor: Medical University of Vienna, Department of Internal medicine I
Enrollment: 48
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

July 1, 2016

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Medical University of Vienna, Department of Internal medicine I

•Signed informed consent obtained before any trial related activities
•Ability to understand the nature and the purpose of the study, including possible risks and side effects; ability to co\-operate with the investigator and to comply with the requirements of the trial
•Men or women aged \=18 years of age with a diagnosis of autoimmune\-mediated haemolytic anemia, antiphospholipid syndrome or immune\-mediated thrombocytopenia
•In female subjects either childbearing potential terminated by surgery or one year post\- menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
•Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
•Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
•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 24

•Previous treatment with rituximab, obinutuzumab, ofatumumab or ocrelizumab within 12 months
•Clinically relevant infection (\<1 week)
•Intravenous immunoglobulins, unless cyclic thrombocytopenia occures
•Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory or neurological diseases, that may interfere with the aim of the study
•Ascertained or presumed hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or major allergic reactions in general, which the investigator considers may compromise the safety of the participants
•Use of medication during 2 weeks before the start of the study, which the investigator considers may affect the validity of the study
•Drug abuse, alcohol (\>1 drinks/day, defined according to USDA Dietary Guidelines)
•Pregnancy (positive pregnancy test at screening or during study phase), lactation or unreliable contraception in female subjects with child\-bearing potential