Chronic idiopathic thrombocytopenic purpura (ITP) MedDRA version: 9.1 Level: LLT Classification code 10051057 Term: Idiopathic thrombocytopenia
Conditions
Interventions
Sponsors
Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Chronic primary ITP since at least 6 months before screening and a platelet count below 50 x 109/l on day 1 or 24 hours before the first dose. 2) No immunosuppressive treatment at day 1 or 24 hours before the first dose. 3) Acceptable contraceptive usage. 4) At least 18 years of age. 5) Signed informed consent. 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
Exclusion criteria: 1) Ongoing immunosuppressive treatment. 2) Presence of malignancy. 3) Pregnancy or lactation. 4) Not willing to participate in the study. 5) Participation in other clinical trial. 6) Not willing to use contraception for 3 months. 7) Ongoing JC virus infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess platelet counts and bleeding tendencies after 3 months of Tysabri treatment. ;Secondary Objective: 1) Response rates. 2) Degree of T-cell accumulation in the bone marrow and change in the number of activated T-cells, regulatory T-cells and antigens involved in lymphocyte homing. 3) Degree of T-cell mediated cytotoxicity before and after treatment. 4) Evaluate if this treatment induces a shift from Th1 (Interferon-?) to Th2 (IL-4 and IL-10) or Th3 (TGFß1) profile. ;Primary end point(s): To asses improvement of platelet counts and bleeding tendencies after 3 months with Tysabri treatment. | — |
Countries
Sweden
Outcome results
None listed