Brief Title
Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs)
Official Title
Clinical Study to Investigate the Long-Term Efficacy, Safety and Immunogenicity of Human-cl rhFVIII in Previously Treated Patients With Severe Haemophilia A - Extension Study to GENA-01
Brief Summary
The purpose of the study is to study the long-term efficacy, safety and tolerability of Human-cl rhFVIII in previously treated patients with severe hemophilia A.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Long-term Immunogenicity
Secondary Outcome
To Determine Long-term Efficacy of Human-cl rhFVIII in the Treatment of Bleeding Episodes and in Surgical Prophylaxis
Condition
Severe Hemophilia A
Intervention
Human-cl rhFVIII
Study Arms / Comparison Groups
Human-cl rhFVIII
Description: Recombinant FVIII derived from a human cell line.
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
Estimated Enrollment
3
Start Date
June 2011
Completion Date
August 2012
Primary Completion Date
August 2012
Eligibility Criteria
Inclusion Criteria: - Completion of GENA-01 study with at least 50 Exposure Days (EDs) and at least 6 months study participation and immediate enrollment into GENA-11 Exclusion Criteria: - Development of FVIII inhibitors (<=0.6 BU), during the course of the GENA-01 study - Development of any severe liver or kidney disease (ALT and AST level > 5 times of upper limit of normal, creatine >120 micro mol/L) during the course of the GENA-01 study
Gender
Male
Ages
12 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Bulgaria
Location Countries
Bulgaria
Administrative Informations
NCT ID
NCT01341912
Organization ID
GENA-11
Responsible Party
Sponsor
Study Sponsor
Octapharma
Study Sponsor
, ,
Verification Date
March 2020