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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00168038
First received: September 12, 2005
Last updated: October 18, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Immune Thrombocytopenic Purpura
Biological: Immunoglobulin Intravenous (Human)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)

Resource links provided by NLM:


Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Platelet Response [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    The platelet response rate is defined as the percentage of subjects responding to treatment with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L within the specified time frame.


Secondary Outcome Measures:
  • Regression of Hemorrhage (Skin) [ Time Frame: up to 29 days ] [ Designated as safety issue: No ]
    Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.

  • Regression of Hemorrhage (Oral Cavity) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.

  • Regression of Hemorrhage (Genitourinary Tract) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.

  • Regression of Hemorrhage (Nose) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.

  • Regression of Hemorrhage (Internal) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.

  • Time to Platelet Response [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Median time to reach a platelet count ≥ 50 x 10^9/L.

  • Duration of Platelet Response [ Time Frame: up to 29 days ] [ Designated as safety issue: No ]
    The number of days the platelet count remained ≥ 50 x 10^9/L.

  • Maximum Platelet Level [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Maximum absolute platelet count achieved over the duration of the study.


Enrollment: 58
Study Start Date: December 2004
Study Completion Date: February 2006
Arms Assigned Interventions
Experimental: IgPro10 Biological: Immunoglobulin Intravenous (Human)
A dose of 1 g IgG per kg body weight (bw) administered on two consecutive days resulting in the total treatment dosage of 2 g IgG per kg bw.
Other Names:
  • Privigen
  • IgPro10

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168038

Locations
Germany
Study Site
Berlin, Germany
Italy
Study Site
Rome, Italy
Poland
Study Site
Bialystok, Poland
Study Site
Gdansk, Poland
Study Site
Lodz, Poland
Study Site
Poznan, Poland
Study Site
Warsaw, Poland
Study Site
Wroclaw, Poland
Russian Federation
Study Site
Moscow, Russian Federation
Study Site (19)
St. Petersburg, Russian Federation
Study Site (20)
St. Petersburg, Russian Federation
Study Site (21)
St. Petersburg, Russian Federation
Ukraine
Study Site
Dnipropetrovsk, Ukraine
Study Site (02)
Kyiv, Ukraine
Study Site (03)
Kyiv, Ukraine
Study Site
Lviv, Ukraine
United Kingdom
Study Site
Taunton, United Kingdom
Sponsors and Collaborators
CSL Behring
Investigators
Study Director: Othmar Zenker, MD CSL Behring
  More Information

Additional Information:
Publications:
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00168038     History of Changes
Other Study ID Numbers: ZLB03_003CR, 2004-000537-11
Study First Received: September 12, 2005
Results First Received: August 22, 2011
Last Updated: October 18, 2011
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

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014