Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10
This study has been completed.
Sponsor:
CSL Behring
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
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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:
|
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
| 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 May 23, 2013