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Human-cl-rhFVIII in Previously Untreated Patients

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Octapharma Identifier:
First received: October 18, 2012
Last updated: October 19, 2016
Last verified: October 2016
Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.

Condition Intervention Phase
Severe Hemophilia A
Biological: Human cl rhFVIII
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunogenicity, Efficacy and Safety of Treatment With Human-cl-rhFVIII in Previously Untreated Patients With Severe Hemophilia A

Resource links provided by NLM:

Further study details as provided by Octapharma:

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: maximum 5 years (100 exposure days) ] [ Designated as safety issue: Yes ]
    Number of patients that develop an inhibitor

Secondary Outcome Measures:
  • Efficacy [ Time Frame: Maximum 5 years (100 exposure days) ] [ Designated as safety issue: No ]
    Efficacy of human cl rhFVIII during prophylactic treatment (frequency of break thorugh blleds) Efficacy of human cl rhFVIII during treatment of bleeds (Number of injections needed to stop a bleed) Efficacy of human cl rhFVIII during surgical prophylaxis (compare expected estimated blood loss versus actual estimated blood loss)

Other Outcome Measures:
  • Safety and tolerability [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Measure vital signs, Adverse events, and standard hematology and chemistry laboratory parameters. This assessment is descriptive)

Enrollment: 110
Study Start Date: February 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human cl rhFVIII Biological: Human cl rhFVIII


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male patients
  • Severe Hemophilia A (FVIII:C <1%)
  • No previous treatment with with FVIII concentrates or other blood prodcuts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01712438

  Show 37 Study Locations
Sponsors and Collaborators
  More Information

Responsible Party: Octapharma Identifier: NCT01712438     History of Changes
Other Study ID Numbers: GENA-05  2012-002554-23 
Study First Received: October 18, 2012
Last Updated: October 19, 2016
Health Authority: United States: Food and Drug Administration
Germany: Paul Ehrlich Institute
Canada: Biologics and Genetic Therapies Directorate
France: National Agency for the safety of Medicine and Health Product
Georgia: Ministry of Labor, Health and Social Affairs
Moldova: Agency for Medicines and Medical Devices
Poland: Office of Registration of Medicinal Products, Medical Devices and Biological Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ukraine: Ministry of Health Ukraine
Spain: Spanish Agency for Medicines and Health Products
Morocco: Direction du Medicament et de la Pharmacie" is not a recognized oversight authority

Keywords provided by Octapharma:
Previously untreated patients

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn processed this record on December 07, 2016