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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