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

Information source: CSL Behring
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Immune Thrombocytopenic Purpura

Intervention: Immunoglobulin Intravenous (Human) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: CSL Behring

Summary

The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic 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.

Clinical Details

Official title: An Open-Label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Response rate, defined by the percentage of patients responding to IgPro10 with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L within 7 days

Secondary outcome:

Regression of hemorrhages

Time to platelet response

Duration of platelet response

Frequency, severity and relatedness of adverse events

Eligibility

Minimum age: 12 Years. Maximum age: 65 Years. Gender(s): Both.

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)

Locations and Contacts

For information on sites in Europe, please contact our clinical research team in, Bern 3000, Switzerland
Additional Information

Starting date: December 2004
Last updated: August 28, 2007

Page last updated: March 21, 2008

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