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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2008-005871-92-SE |
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Date of registration:
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10/12/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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05/02/2009 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005871-92 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Sweden
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 9.1
Level: LLT
Classification code 10051057
Term: Idiopathic thrombocytopenia
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Intervention(s)
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Trade Name: Tysabri
Product Name: Tysabri
Pharmaceutical Form: Concentrate for solution for infusion
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Primary Outcome(s)
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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.
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Primary end point(s): To asses improvement of platelet counts and bleeding tendencies after 3 months with Tysabri treatment.
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Main Objective: To assess platelet counts and bleeding tendencies after 3 months of Tysabri treatment.
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Secondary ID(s)
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Sahlgrenska/Hematology/2008:1
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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