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Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10
This study has been completed.
Sponsored by: CSL Behring
Information provided by: CSL Behring
ClinicalTrials.gov Identifier: NCT00168038
  Purpose

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.


Condition Intervention Phase
Immune Thrombocytopenic Purpura
Drug: Immunoglobulin Intravenous (Human)
Phase III

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: An Open-Label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)

Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • 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 Measures:
  • Regression of hemorrhages
  • Time to platelet response
  • Duration of platelet response
  • Frequency, severity and relatedness of adverse events

Estimated Enrollment: 60
Study Start Date: December 2004
  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168038

Locations
Switzerland
For information on sites in Europe, please contact our clinical research team in
Bern, Switzerland, 3000
Sponsors and Collaborators
CSL Behring
  More Information

Study ID Numbers: ZLB03_003CR
Study First Received: September 12, 2005
Last Updated: August 28, 2007
ClinicalTrials.gov Identifier: NCT00168038  
Health Authority: Germany: Paul-Ehrlich-Institut;   Russia: Pharmacological Committee, Ministry of Health;   Ukraine: Ministry of Health;   United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Italy: Ministry of Health;   Poland: Ministry of Health

Keywords provided by CSL Behring:
Chronic Immune Thrombocytopenic Purpura
Chronic Idiopathic Thrombocytopenic Purpura
Werlhofs Disease
Autoimmune Thrombocytopenia
Immunglobulin Intravenous
Chronic ITP
Platelet count
Thrombocytopenia

Study placed in the following topic categories:
Purpura
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemostatic Disorders
Purpura, Thrombocytopenic
Signs and Symptoms
Thrombocytopathy
Antibodies
Thrombocytopenia
Immunoglobulins, Intravenous
Thrombocytopenic purpura, autoimmune
Purpura, Thrombocytopenic, Idiopathic
Rho(D) Immune Globulin
Immunoglobulins

Additional relevant MeSH terms:
Skin Manifestations
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009