Clinical trial NCT01063595: A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD
Official 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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Comparison of Octaplas LG and Octaplas SD
Keywords: Octaplas LG
Octaplas SD
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI
timeFrame: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration
measure: Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C
timeFrame: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration
Secondary outcomes:
measure: Concentration of Plasmin Inhibitor
timeFrame: From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology - Medical University Vienna
Study officials:
References:
citation: 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.