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A Trial to Investigate the Relative Efficacy, Safety and Tolerability of OctaplasLG 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: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

The treatment day will start with plasmapheresis (600 mL), then transfusion of either OctaplasLG or OctaplasSD will be randomly assigned. Safety, efficacy and tolerability will be assessed by clinical and laboratory parameters. The overall duration per subject will be 1.5 months.


Condition Intervention Phase
Healthy
 Biological: Octaplas SD (Plasma product)
Biological: OctaplasLG (Plasma product)
 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 1 Trial in Healthy Volunteers to Investigate the Relative Efficacy, Safety and Tolerability in Healthy Volunteers to Investigate the Relative Efficacy, Safety and Tolerability of OctaplasLG Versus Octaplas SD

Further study details as provided by Octapharma:

Primary Outcome Measures:
  • Coagulation factors [ Time Frame: Laboratory parameters will be determined before and immediately after plasmapheresis; and 15 min., 2hrs., 24 hrs, and 7 days after end of IMP administration ] [ Designated as safety issue: No ]
  • Activated partial thromboplastin time (aPTT), prothrombin time (PT), protein C [ Time Frame: Laboratory parameters will be determined before and immediately after plasmapheresis; and 15 min., 2hrs., 24 hrs, and 7 days after end of IMP administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Laboratory parameters (hematology, clinical chemistry); overall tolerability, vital signs [ Time Frame: Laboratory parameters will be determined before and immediately after plasmapheresis; and 15 min., 2hrs., 24 hrs, and 7 days after end of IMP administration ] [ Designated as safety issue: No ]
  • Overall tolerability [ Time Frame: Laboratory parameters will be determined before and immediately after plasmapheresis; and 15 min., 2hrs., 24 hrs, and 7 days after end of IMP administration ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: Laboratory parameters will be determined before and immediately after plasmapheresis; and 15 min., 2hrs., 24 hrs, and 7 days after end of IMP administration ] [ Designated as safety issue: No ]

Enrollment: 60
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
Active Comparator: Octaplas SD Biological: Octaplas SD (Plasma product)
The treatment day will start with plasmapheresis (600mL), then transfusion of either OctaplasLG or Octaplas SD randomly assigned. Laboratory parameters will be determined before and immediately after plasmapheresis; and 15 min., 2hrs., 24 hrs, and 7 days after end of IMP administration.
Experimental: OctaplasLG Biological: OctaplasLG (Plasma product)
The treatment day will start with plasmapheresis (600mL), then transfusion of either OctaplasLG or Octaplas SD randomly assigned. Laboratory parameters will be determined before and immediately after plasmapheresis; and 15 min., 2hrs., 24 hrs, and 7 days after end of IMP administration.

  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 hte 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 (HCG - based assay)
  • Women must have sufficient methods of contraception (e.g. 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 FFP, 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 HBs-Ag, HCV, HIV-1/2 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 IMP administration within the last 4 weeks
  Contacts and Locations
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

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01063595     History of Changes
Other Study ID Numbers: LAS-203
Study First Received: February 4, 2010
Last Updated: October 10, 2012
Health Authority: Austria: Agency for Health and Food Safety
United States: Food and Drug Administration

Keywords provided by Octapharma:
To test efficacy, safety, and tolerability of Octaplas LG versus Octaplas SD

ClinicalTrials.gov processed this record on June 18, 2013