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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01063595
First received: February 4, 2010
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Comparison of Octaplas LG and Octaplas SD
Biological: Octaplas LG
Biological: Octaplas SD
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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®

Further study details as provided by Octapharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Concentration of Plasmin Inhibitor [ Time Frame: From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis ] [ Designated as safety issue: No ]
    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.


Enrollment: 63
Study Start Date: December 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Octaplas LG
Participants received 1200 mL of Octaplas LG intravenously once.
Biological: Octaplas LG
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.
Active Comparator: Octaplas SD
Participants received 1200 mL of Octaplas SD intravenously once.
Biological: Octaplas SD
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063595

Locations
Austria
Department of Clinical Pharmacology - Medical University Vienna
Vienna, Austria
Sponsors and Collaborators
Octapharma
  More Information

No publications provided by Octapharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01063595     History of Changes
Other Study ID Numbers: LAS-203
Study First Received: February 4, 2010
Results First Received: March 31, 2014
Last Updated: May 12, 2014
Health Authority: Austria: Agency for Health and Food Safety
United States: Food and Drug Administration

Keywords provided by Octapharma:
Octaplas LG
Octaplas SD

ClinicalTrials.gov processed this record on September 16, 2014