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

May 12, 2014 updated by: Octapharma

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®

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Department of Clinical Pharmacology - Medical University Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Octapharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LAS-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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