A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD

Study Overview
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Brief Summary
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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.

Official Title
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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®

Conditions
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Comparison of Octaplas LG and Octaplas SD

Intervention / Treatment
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* Biological: Octaplas LG
* Biological: Octaplas SD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octaplas LG<br>Participants received 1200 mL of Octaplas LG intravenously once. | Biological: Octaplas LG<br>* 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.<br>|
| Active Comparator: Octaplas SD<br>Participants received 1200 mL of Octaplas SD intravenously once. | Biological: Octaplas SD<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Octaplas LG, Octaplas SD