An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.

Bio Products Laboratory

Overview

The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Haemophilia A

Interventions

Optivate® (Human Coagulation Factor VIII)BIOLOGICAL

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover. Exclusion Criteria: \-

Locations (11)

Klinika Haematologii, Akademia Medyczna w Bialymstokiu, ul.

Bialystok, Poland

Klinika Haematologii, Akademia Medyczna w Gdansku, u.

Gdansk, Poland

Klinika Haematologii, Akademia Medyczna w Lodzi, ul.

Lodz, Poland

Outcomes

Primary Outcomes

Incremental Recovery

Time frame: Comparison of Baseline with 3 months post-baseline

Data from ClinicalTrials.gov

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