Brief Title
Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
Official Title
Immunogenicity, Efficacy and Safety of Treatment With Human-cl-rhFVIII in Previously Untreated Patients With Severe Hemophilia A
Brief Summary
Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors
Secondary Outcome
Frequency of Spontaneous Break-through Bleeds
Condition
Severe Hemophilia A
Intervention
Human cl rhFVIII
Study Arms / Comparison Groups
Human cl rhFVIII
Description:
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
110
Start Date
February 2013
Completion Date
December 20, 2019
Primary Completion Date
December 14, 2018
Eligibility Criteria
Inclusion Criteria: - Male patients - Severe Hemophilia A (FVIII:C <1%) - No previous treatment with FVIII concentrates or other blood products containing FVIII Exclusion Criteria: - Diagnosis with a coagulation disorder other than Hemophilia A - Severe liver or kidney disease - Concomitant treatment with any systemic immunosuppressive drug
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Sigurd Knaub, ,
Location Countries
Belarus
Location Countries
Belarus
Administrative Informations
NCT ID
NCT01712438
Organization ID
GENA-05
Secondary IDs
2012-002554-23
Responsible Party
Sponsor
Study Sponsor
Octapharma
Study Sponsor
Sigurd Knaub, Study Director, Octapharma
Verification Date
December 2020