Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10

CSL Behring

Status and phase

Completed

Phase 3

Conditions

Immune Thrombocytopenic Purpura

Treatments

Biological: Immunoglobulin Intravenous (Human)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00168038

ZLB03_003CR

2004-000537-11 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic immune thrombocytopenic purpura (ITP). The main efficacy parameter is the proportion of patients responding to treatment by an increase of platelet count to ≥ 50 x 10^9/L.

Enrollment

58 patients

Sex

All

Ages

12 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

Planned splenectomy throughout the study period
Treatment with IVIG or anti-D immunoglobulin within 3 weeks prior to screening
Treatment with immunosuppressive or other immunomodulatory drugs within 3 weeks prior to screening
Treatment with intravenous 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
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
Positive direct Coombs test
Patients with one of the following concomitant diseases Clinical active SLE Known or suspected HIV infection Acute hepatitis Clinically active chronic hepatitis Lymphoproliferative 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)