EUCTR2004-000537-11-DE
Active, not recruiting
Not Applicable
An open-label, multicenter study on the efficacy and safety of IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP)
ZLB Behring AG0 sites60 target enrollmentSeptember 14, 2004
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- 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.
- Sponsor
- ZLB Behring AG
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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 \< 10 g/dL
- •Total bilirubin \> 1\.5 x upper normal limit
- •ALAT \> 2\.5 x upper normal limit
Outcomes
Primary Outcomes
Not specified
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