En fas 1 studie av effekt av Tysabri (natalizumab), en IgG4 humaniserad monoklonal antikropp specifik mot VLA-4 (integrin alfa-4), administrerad som infusion 1 gång/månad under 3 månader hos patienter med kronisk idiopatisk trombocytopen purpura (ITP). - Tysabri for ITP

Phase 1

Conditions: Chronic idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 9.1Level: LLTClassification code 10051057Term: Idiopathic thrombocytopenia

Registration Number: EUCTR2008-005871-92-SE

Lead Sponsor: Sahlgrenska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess platelet counts and bleeding tendencies after 3 months of Tysabri treatment.<br><br>;Secondary Objective: 1) Response rates.<br>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. <br>3) Degree of T-cell mediated cytotoxicity before and after treatment. <br>4) Evaluate if this treatment induces a shift from Th1 (Interferon-?) to Th2 (IL-4 and IL-10) or Th3 (TGFß1) profile.<br><br>;Primary end point(s): To asses improvement of platelet counts and bleeding tendencies after 3 months with Tysabri treatment.

Secondary Outcome Measures