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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT00989196
First received: September 30, 2009
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hemophilia A
 Biological: recombinant FVIII
Biological: Kogenate FS
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Further study details as provided by Octapharma:

Primary Outcome Measures:
  • Area under the curve [ Time Frame: Within the first few weeks after screening ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: May 2010
Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: recombinant FVIII Biological: recombinant FVIII
50 IU/kg for PK dose
Active Comparator: Kogenate FS Biological: Kogenate FS
50 IU/kg for PK dose

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989196

Locations
United States, California
UCLA Orthodpedic Hospital
Los Angeles, California, United States, 90007
University of California, Davis
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80045
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
United States, Illinois
RUSH University Medical Center
Chicago, Illinois, United States, 60612
United States, New Jersey
University of Medicine and Dentistry
New Brunswick, New Jersey, United States, 08903
Bulgaria
Prof. Lissitchkov
Sofia, Bulgaria
Germany
Medizinische Hochschule
Hannover, Niedersachsen, Germany
Vivantes Klinikum
Berlin, Germany
Sponsors and Collaborators
Octapharma
Investigators
Study Director: Sigurd Knaub, PhD Octapharma
  More Information

No publications provided

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT00989196     History of Changes
Other Study ID Numbers: GENA-01
Study First Received: September 30, 2009
Last Updated: October 2, 2012
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
 Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013