A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.

Overview

The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compare the first and second pharmacokinetic assessments on Optivate® (and recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and safety.

Full Title of Study: “An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
  • Study Primary Completion Date: January 2004

Interventions

  • Biological: Optivate® (Human Coagulation Factor VIII)

Arms, Groups and Cohorts

  • Active Comparator: Current Factor VIII
    • Optivate® (Human Coagulation Factor VIII)
  • Experimental: Optivate®
    • Optivate® (Human Coagulation Factor VIII)

Clinical Trial Outcome Measures

Primary Measures

  • PK parameters for FVIII:C
    • Time Frame: Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose

Participating in This Clinical Trial

Inclusion Criteria

  • Previously treated subjects with severe Haemophilia A (<2% basal FVIII activity) without inhibitor to Factor VIII, at least 12 years of age, currently receiving FVIII concentrate and with more than 20 exposure days. Exclusion Criteria:

-

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Bio Products Laboratory
  • Provider of Information About this Clinical Study
    • Sponsor

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