Brief Title
A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
Official Title
An Open Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.
Brief Summary
The main objectives of this study are: - to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed). - to assess clinical outcome when treating a bleed with Optivate®. - to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. . - to assess FVIII inhibitor development during the study.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Consumption of FVIII
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
November 2003
Primary Completion Date
January 2005
Eligibility Criteria
Inclusion Criteria: - Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII. Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study. Exclusion Criteria: -
Gender
All
Ages
N/A - 6 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Poland
Location Countries
Poland
Administrative Informations
NCT ID
NCT02246894
Organization ID
8VWF05
Responsible Party
Sponsor
Study Sponsor
Bio Products Laboratory
Study Sponsor
, ,
Verification Date
February 2018