Brief Title
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A
Official Title
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of Human-cl rhFVIII, a Newly Developed Human Cell-line Derived Recombinant FVIII Concentrate in Previously Treated Patients With Severe Hemophilia A
Brief Summary
This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
The Area Under the Concentration Curve for Human-cl rhFVIII Compared to Kogenate FS
Secondary Outcome
Invivo Half-life (T1/2) for Human-cl rhFVIII Compared to Kogenate FS
Condition
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
22
Start Date
May 2010
Completion Date
September 2012
Primary Completion Date
October 2011
Eligibility Criteria
Inclusion Criteria: - Severe hemophilia A (FVIII:C <= 1%) - Male subjects between 12 and 65 years of age - Body weight 25 kg to 110 kg - Previously treated with FVIII concentrate for at least 150 EDs Exclusion Criteria: - Other coagulation disorder than hemophilia A - Present or past FVIII inhibitor activity
Gender
Male
Ages
12 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Sigurd Knaub, PhD, ,
Location Countries
Bulgaria
Location Countries
Bulgaria
Administrative Informations
NCT ID
NCT00989196
Organization ID
GENA-01
Responsible Party
Sponsor
Study Sponsor
Octapharma
Study Sponsor
Sigurd Knaub, PhD, Study Director, Octapharma
Verification Date
September 2019