Brief Title
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
Official Title
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
Brief Summary
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 Phase
Phase 3
Study Type
Interventional
Primary Outcome
Incremental Recovery
Condition
Haemophilia A
Intervention
Optivate® (Human Coagulation Factor VIII)
Study Arms / Comparison Groups
Optivate®
Description: Optivate® (Human Coagulation Factor VIII)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Start Date
September 2001
Primary Completion Date
August 2004
Eligibility Criteria
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: -
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Poland
Location Countries
Poland
Administrative Informations
NCT ID
NCT02246868
Organization ID
8VWFSE
Responsible Party
Sponsor
Study Sponsor
Bio Products Laboratory
Study Sponsor
, ,
Verification Date
February 2018