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Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.
The primary objective of the study was to investigate the efficacy of Octagam® 10% in correcting platelet count. The blood count as well as laboratory chemistry were checked repeatedly up to day 21.
The secondary objective of the study was to investigate the safety of Octagam® 10%. Safety was assessed by monitoring vital signs, evaluating adverse events, assessing laboratory parameters, and by viral safety testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octagam 10% 1 g/kg/day | Experimental | Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octagam 10% | Drug | Octagam 10% was supplied as a ready-to-use solution in glass bottles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Clinical Response | A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7. | Day 2 to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve a Clinical Response | A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7. | Day 2 to Day 7 |
| Maximum Platelet Count | Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Frenzel, MD | Octapharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Octapharma for information | Vienna | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20863431 | Derived | Robak T, Mainau C, Pyringer B, Chojnowski K, Warzocha K, Dmoszynska A, Straub J, Imbach P. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam(R) 10%) in patients with immune thrombocytopenia. Hematology. 2010 Oct;15(5):351-9. doi: 10.1179/102453310X12719010991867. |
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One participant was incorrectly enrolled in the study and was not included in the efficacy analyses but was included in the safety population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Octagam 10% 1 g/kg/Day | Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population: All participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Octagam 10% 1 g/kg/Day | Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With a Clinical Response | A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7. | Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count. | Posted | Number | Percentage of participants | Day 2 to Day 7 |
|
|
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Safety population: All participants who received at least 1 dose of study medication.
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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 | Octagam 10% 1 g/kg/Day | Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Eppolito | Octapharma USA | 201 604-1155 | michael.eppolito@octapharma.com |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
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| Day 2 to the end of the study (Day 63) |
| Duration of the Clinical Response | The duration of the clinical response was the number of days that the platelet count remained ≥ 50*10^9/L. Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. A conservative method was used to calculate the duration of the clinical response. For example, if the platelet count was ≥ 50*10^9/L on Day 7 and dropped below 50*10^9/L at Day 14, Day 7 was used as the last day to calculate the duration of the clinical response. The same procedure was used if the platelet count dropped below 50*10^9/L at Day 21 from Day 14 or Day 63 from Day 21. | Day 2 to the end of the study (Day 63) |
| Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7 | The investigator evaluated the severity of bleeding using the following rating scale: None (definitely no haemorrhage of any kind), Minor (few petechiae [≤ 100 total] and/or ≤ 5 small bruises [≤ 3 cm diameter], no mucosal bleeding), Mild (many petechiae [> 100 total] and/or > 5 large bruises [> 3 cm diameter], no mucosal bleeding), Moderate (overt mucosal bleeding [epistaxis, gum bleeding, oropharyngeal blood blisters, menorrhagia, gastrointestinal bleeding, etc] that does not require immediate medical attention or intervention). | Day 7 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Time to Achieve a Clinical Response | A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7. | Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count. Only participants with a clinical response were included in the analysis. | Posted | Mean | Standard Deviation | Days | Day 2 to Day 7 |
|
|
|
| Secondary | Maximum Platelet Count | Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported. | Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count. | Posted | Mean | Standard Deviation | *10^9/L | Day 2 to the end of the study (Day 63) |
|
|
|
| Secondary | Duration of the Clinical Response | The duration of the clinical response was the number of days that the platelet count remained ≥ 50*10^9/L. Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. A conservative method was used to calculate the duration of the clinical response. For example, if the platelet count was ≥ 50*10^9/L on Day 7 and dropped below 50*10^9/L at Day 14, Day 7 was used as the last day to calculate the duration of the clinical response. The same procedure was used if the platelet count dropped below 50*10^9/L at Day 21 from Day 14 or Day 63 from Day 21. | Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count. Only participants with a clinical response were included in the analysis. | Posted | Mean | Standard Deviation | Days | Day 2 to the end of the study (Day 63) |
|
|
|
| Secondary | Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7 | The investigator evaluated the severity of bleeding using the following rating scale: None (definitely no haemorrhage of any kind), Minor (few petechiae [≤ 100 total] and/or ≤ 5 small bruises [≤ 3 cm diameter], no mucosal bleeding), Mild (many petechiae [> 100 total] and/or > 5 large bruises [> 3 cm diameter], no mucosal bleeding), Moderate (overt mucosal bleeding [epistaxis, gum bleeding, oropharyngeal blood blisters, menorrhagia, gastrointestinal bleeding, etc] that does not require immediate medical attention or intervention). | Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count. | Posted | Number | Percentage of participants | Day 7 |
|
|
|
| 14 |
| 116 |
| 79 |
| 116 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| 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 |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|
|
| Moderate |
|
| Missing |
|