Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00989196
• Date of registration: 30/09/2009
• Primary sponsor: Octapharma
• Public title: Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A
• Scientific 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
• Date of first enrolment: May 2010
• Target sample size: 22
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00989196
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Bulgaria, Germany, United States

Contacts

• Name: Sigurd Knaub, PhD
• Affiliation: Octapharma

Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Hemophilia A

Intervention(s)

Biological: Kogenate FS

Biological: recombinant FVIII

Primary Outcome(s)

Area under the curve [Time Frame: Within the first few weeks after screening]

Secondary ID(s)

GENA-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors