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.
Conditions
Interventions
Product Name: IgPro10
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human Immunoglobulin
Concentration unit: g/l gram(s)/litre
Concentration number: 100-
Sponsors
ZLB Behring AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) /L | — |
Countries
Germany, Italy
Outcome results
None listed