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

Bio Products Laboratory

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Von Willebrand Disease

Interventions

Optivate® (Human Coagulation Factor VIII)BIOLOGICAL

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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: \-

Locations (8)

Klinika Haematologii, Akademia Medyczna w Gdansku, ul.

Debinki 7, 80-211 Gdansk, Poland

Klinika Haematologii, Akademia Medyczna w Lublinie, ul.

Dr K Jaczewskiego 8, 20-090, Lublin, Poland

Klinika Haematologii, Akademia Medyczna w Lodzi, ul.

Pabianicka 62, 93-513 Lodz, Poland

Outcomes

Primary Outcomes

PK parameters for FVIII:C

Time frame: Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose

Data from ClinicalTrials.gov

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