An open-label, multicenter study on the efficacy and safety of IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP)
- Conditions
- Immune thrombocytopenic purpura (ITP) is the most common autoimmune disease. It is a bleeding disorder characterized by decreased counts of circulating platelets and normal or increased numbers of megakaryocytes in the bone marrow.
- Registration Number
- EUCTR2004-000537-11-DE
- Lead Sponsor
- ZLB Behring AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Male or female patients aged 18 – 65 years
Diagnosis of chronic ITP defined by:
Failure to find other causes of thrombocytopenia
Platelet count = 150 x 10 (9) /L over 6 months or response to a previous
treatment with subsequent decrease in platelet count even if duration of
chronic ITP is less than 6 months
Platelet counts = 20 x 10 (9) /L
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) no
F.1.3.1 Number of subjects for this age range
Treatment with IVIG or anti-D immunoglobulin within 3 weeks prior to screening.
Treatment with IV steroids within 10 days prior to screening.
Change of oral steroid treatment within 15 days prior to screening.
Patients with known or suspected hypersensitivity to immunoglobulins or previous severe side effects to immunoglobulin therapy.
Patients with a history of migraine.
Patients with known hyperprolinemia.
Abnormal results in the following laboratory parameters:
Hemoglobin < 10 g/dL
Total bilirubin > 1.5 x upper normal limit
ALAT > 2.5 x upper normal limit
ASAT > 2.5 x upper normal limit
Creatinine > 1.5 x upper normal limit
Urea > 1.5 x upper normal limit
Patients with low serum IgA level, defined by < 50% lower normal limit.
Patients with one of the following concomitant diseases:
Clinical active SLE
Lymphoproliterative disease
Heart failure Grade III or IV according to the New York Heart Association
classification
Any other concomitant disease that has influence on the clotting system (i.e. hemophilia)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The study is designed to assess the efficacy, tolerability and safety of IgPro10 ;Secondary Objective: ;Primary end point(s): Response defined by an elevation of platelet count within 7 days after the first study drug administration to at least 50 x 10 (9) /
- Secondary Outcome Measures
Name Time Method