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The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters. The secondary objective of the study was to compare the safety and tolerability of Octaplas LG with Octaplas SD in terms of haematological and clinical chemistry parameters and adverse event monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octaplas LG | Experimental | Participants received 1200 mL of Octaplas LG intravenously once. |
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| Octaplas SD | Active Comparator | Participants received 1200 mL of Octaplas SD intravenously once. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octaplas LG | Biological | Octaplas LG was composed of human coagulation-active plasma treated with solvent/detergent for 1-1.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. An additional manufacturing step, involving an affinity ligand gel, removed prion proteins. Octaplas LG was provided frozen in pyrogen free plastic bags. |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI | Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration. | From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration |
| Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C | Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration. | From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Plasmin Inhibitor | Values of plasmin inhibitor were measured by validated assays from blood samples obtained 30 minutes before plasmapheresis, 5 minutes after the end of plasmapheresis, 15 minutes and 2 hours after the end of study drug administration, and 24 hours and 7 days after initiation of plasmapheresis. The concentration of plasmin inhibitor is reported as the percentage of plasmin inhibition. A higher concentration of plasmin inhibitor results in a higher percentage of plasmin inhibition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology - Medical University Vienna | Vienna | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23320451 | Derived | Jilma-Stohlawetz P, Kursten FW, Horvath M, Leitner G, List J, Marcek J, Quehenberger P, Schwameis M, Bartko J, Derhaschnig U, Jilma B. Recovery, safety, and tolerability of a solvent/detergent-treated and prion-safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers. Transfusion. 2013 Sep;53(9):1906-17. doi: 10.1111/trf.12075. Epub 2013 Jan 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Octaplas SD First, Then Octaplas LG | Participants received 1200 mL of Octaplas SD intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas LG intravenously once. |
| FG001 | Octaplas LG First, Then Octaplas SD | Participants received 1200 mL of Octaplas LG intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas SD intravenously once. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled in Study and Randomized |
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| First Intervention |
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| Second Intervention |
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Safety population: All participants who received at least 1 of the study treatments in any study period.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received 1200 mL of Octaplas LG intravenously once and 1200 mL of Octaplas SD intravenously once in a crossover design. |
| 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 |
| 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 | Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI | Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration. | Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods. | Posted | Mean | Standard Deviation | Percentage change | From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration |
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Safety population: All participants who received at least 1 of the study treatments in any study period.
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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 | Octaplas LG | Participants received 1200 mL of Octaplas LG intravenously once. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic shock | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Eppolito, Director, Clinical Operations Immunology and ICU Medicine | Octapharma USA | 201 604-1155 | michael.eppolito@octapharma.com |
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| Octaplas SD | Biological | Octaplas SD was composed of human coagulation-active plasma treated with solvent/detergent for 4-4.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. Octaplas SD was provided frozen in pyrogen free plastic bags. |
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| From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis |
| Withdrawn by the Investigator |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Octaplas SD | Participants received 1200 mL of Octaplas SD intravenously once. |
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| Primary | Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C | Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration. | Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods. | Posted | Mean | Standard Deviation | Percentage change | From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration |
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| Secondary | Concentration of Plasmin Inhibitor | Values of plasmin inhibitor were measured by validated assays from blood samples obtained 30 minutes before plasmapheresis, 5 minutes after the end of plasmapheresis, 15 minutes and 2 hours after the end of study drug administration, and 24 hours and 7 days after initiation of plasmapheresis. The concentration of plasmin inhibitor is reported as the percentage of plasmin inhibition. A higher concentration of plasmin inhibitor results in a higher percentage of plasmin inhibition. | Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods. | Posted | Mean | Standard Deviation | Percentage inhibition | From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis |
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| 1 |
| 60 |
| 34 |
| 60 |
| EG001 | Octaplas SD | Participants received 1200 mL of Octaplas SD intravenously once. | 0 | 60 | 39 | 60 |
| Urticaria | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Paraesthesia oral | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Vertigo | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Protein C |
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| Post-transfusion 15 minutes |
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| Post-transfusion 2 hours |
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| Post-plasmapheresis 24 hours |
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| Post-plasmapheresis 7 days |
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