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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000537-11 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgPro10 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoglobulin Intravenous (Human) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Response | 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Regression of Hemorrhage (Skin) | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Othmar Zenker, MD | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Berlin | Germany | ||||
| Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19635187 | Result | Robak T, Salama A, Kovaleva L, Vyhovska Y, Davies SV, Mazzucconi MG, Zenker O, Kiessling P; International Privigen in ITP Study Group. Efficacy and safety of Privigen, a novel liquid intravenous immunoglobulin formulation, in adolescent and adult patients with chronic immune thrombocytopenic purpura. Hematology. 2009 Aug;14(4):227-36. doi: 10.1179/102453309X439773. |
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One enrolled subject was withdrawn prior to receiving treatment due to a non-fatal adverse event. This subject was not included in the analyses.
The study was performed as a multicenter study at 17 centers, 6 in Poland, 4 in the Ukraine, 4 in Russia, 1 in Germany, 1 in Italy and 1 in the United Kingdom (UK).
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| ID | Title | Description |
|---|---|---|
| FG000 | IgPro10 | All subjects treated with IgPro10 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| up to 29 days |
| Regression of Hemorrhage (Oral Cavity) | 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. | 29 days |
| Regression of Hemorrhage (Genitourinary Tract) | 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. | 29 days |
| Regression of Hemorrhage (Nose) | 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. | 29 days |
| Regression of Hemorrhage (Internal) | 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. | 29 days |
| Time to Platelet Response | Median time to reach a platelet count ≥ 50 x 10^9/L. | 29 days |
| Duration of Platelet Response | The number of days the platelet count remained ≥ 50 x 10^9/L. | up to 29 days |
| Maximum Platelet Level | Maximum absolute platelet count achieved over the duration of the study. | 29 days |
| Rome |
| Italy |
| Study Site | Bialystok | Poland |
| Study Site | Gdansk | Poland |
| Study Site | Lodz | Poland |
| Study Site | Poznan | Poland |
| Study Site | Warsaw | Poland |
| Study Site | Wroclaw | Poland |
| Study Site | Moscow | Russia |
| Study Site (19) | Saint Petersburg | Russia |
| Study Site (20) | Saint Petersburg | Russia |
| Study Site (21) | Saint Petersburg | Russia |
| Study Site | Dnipropetrovsk | Ukraine |
| Study Site (02) | Kyiv | Ukraine |
| Study Site (03) | Kyiv | Ukraine |
| Study Site | Lviv | Ukraine |
| Study Site | Taunton | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IgPro10 | All subjects treated with IgPro10 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Platelet Response | 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. | Intention to treat (ITT) analysis. The ITT population comprised all subjects who received at least once study medication. | Posted | Number | 95% Confidence Interval | Percent of participants | 7 days |
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| Secondary | Regression of Hemorrhage (Skin) | 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. | The number of participants analyzed represents the number of subjects in the ITT population with skin bleeding at baseline and respective post-baseline assessment. | Posted | Number | participants | up to 29 days |
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| Secondary | Regression of Hemorrhage (Oral Cavity) | 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. | The number of participants analyzed represents the number of subjects in the ITT population with oral cavity bleeding at baseline and respective post-baseline assessment. | Posted | Number | participants | 29 days |
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| Secondary | Regression of Hemorrhage (Genitourinary Tract) | 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. | The number of participants analyzed represents the number of subjects in the ITT population with genitourinary tract bleeding at baseline and respective post-baseline assessment. | Posted | Number | participants | 29 days |
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| Secondary | Regression of Hemorrhage (Nose) | 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. | The number of participants analyzed represents the number of subjects in the ITT population with nose bleeding at baseline and respective post-baseline assessment. | Posted | Number | participants | 29 days |
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| Secondary | Regression of Hemorrhage (Internal) | 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. | The number of participants analyzed represents the number of subjects in the ITT population with internal bleeding at baseline and respective post-baseline assessment. | Posted | Number | participants | 29 days |
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| Secondary | Time to Platelet Response | Median time to reach a platelet count ≥ 50 x 10^9/L. | ITT analysis. The ITT population comprised all subjects who received at least once study medication. | Posted | Median | Inter-Quartile Range | days | 29 days |
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| Secondary | Duration of Platelet Response | The number of days the platelet count remained ≥ 50 x 10^9/L. | Analyzed for responders in the ITT population, i.e., only subjects with at least one platelet measurement ≥ 50 x 10^9/L after start of treatment | Posted | Median | Inter-Quartile Range | days | up to 29 days | Responders | Participants |
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| Secondary | Maximum Platelet Level | Maximum absolute platelet count achieved over the duration of the study. | ITT analysis. The ITT population comprised all subjects who received at least once study medication. | Posted | Median | Full Range | 10^9/L | 29 days |
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28 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IgPro10 | All subjects treated with IgPro10 | 3 | 57 | 52 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
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| Meningitis aseptic | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Sudden hearing loss | Ear and labyrinth disorders | MedDRA (9.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (9.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
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| Hyperthermia | General disorders | MedDRA (9.0) | Systematic Assessment |
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| Bilirubin conjugated increased | Investigations | MedDRA (9.0) | Systematic Assessment |
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| Blood bilirubin unconjugated increased | Investigations | MedDRA (9.0) | Systematic Assessment |
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| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Coombs direct test positive | Investigations | MedDRA (9.0) | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Anisocytosis | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
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| Coombs test positive | Investigations | MedDRA (9.0) | Systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA (9.0) | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (9.0) | Systematic Assessment |
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The investigator must provide a copy of any results communication to the sponsor for review at least 30 days prior to public release. The sponsor may request any changes necessary to prevent forfeiture of patent rights to data not in the public domain. For a multi-center study, the investigator must wait (i) at least 1 year after the study is completed at all sites or (ii) until notified by the sponsor that no multi-center publication is planned before seeking publication review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | CSL Behring | clinicaltrials@cslbehring.com |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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