Department of Clinical Pharmacology - Medical University Vienna
Vienna, Austria
Completed
NCT Number: NCT01063595
A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Capable of understanding and complying with all aspects of the protocol.
- Signed Informed Consent.
- Capable of understanding the plasmapheresis information sheet and sign it.
- Healthy male or female volunteers, age 18 years or older.
- Women must have negative pregnancy test (human chorionic gonadotropin [HCG] based assay).
- Women must have sufficient methods of contraception (eg, intrauterine device, oral contraception, etc).
- No clinically relevant abnormalities in medical history and general physical examination.
- Standard health insurance.
Exclusion criteria
- Pregnancy or lactation.
- Tattoos within the last 3 months.
- Subject was treated therapeutically with fresh frozen plasma, blood, or plasma-derived products within the last 6 months.
- Hypersensitivity to blood products or plasma proteins.
- History of angioedema.
- History of coagulation or bleeding disorder or any other known abnormality affecting coagulation, fibrinolysis, or platelet function.
- Any clinically significant abnormal laboratory values.
- IgA deficiency.
- Seropositivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus type 1 or type 2 antibodies.
- Symptoms of a clinically relevant illness within 3 weeks before the first trial day.
- History of or suspected drug or alcohol abuse.
- Subjects currently participating in another clinical study.
- Any investigational medicinal product administration within the last 4 weeks.
Treatment and study plan
Octaplas LG
BiologicalOctaplas 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.
Octaplas SD
BiologicalOctaplas 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.
Primary outcomes
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Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI
Time frame: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration
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.
-
Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C
Time frame: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration
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.
Secondary outcomes
-
Concentration of Plasmin Inhibitor
Time frame: From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis
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.
Sponsors and collaborators
Lead sponsor
Octapharma
Industry
Registry information
Official study title
A Comparative, Open-label, Randomized, Cross-over Phase I Trial in Healthy Volunteers to Investigate the Relative Efficacy, Safety and Tolerability of Octaplas LG™ vs. Octaplas®
Important dates
- Study start
- 2009
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Feb 5, 2010
- Registry last updated
- May 20, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.