Brief Title
Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
Official Title
Extension Study for Patients Who Completed GENA-05 (NuProtect)- to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
Brief Summary
The purpose of the study is to collect long-term data on 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
48
Start Date
April 2014
Completion Date
December 27, 2018
Primary Completion Date
December 27, 2018
Eligibility Criteria
Inclusion Criteria: 1. Patients who completed GENA-05 in accordance with the study protocol Exclusion Criteria: 1. Severe liver or kidney disease 2. Concomitant treatment with any systemic immunosuppressive drug; 3. Other FVIII concentrate than Human-cl rhFVIII was received between completion visit of GENA-05 and start of GENA-15 (except emergency cases).
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Sigurd Knaub, PhD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01992549
Organization ID
GENA-15
Responsible Party
Sponsor
Study Sponsor
Octapharma
Study Sponsor
Sigurd Knaub, PhD, Study Director, Octapharma
Verification Date
December 2020