Human-cl-rhFVIII in Previously Untreated Patients

This study is currently recruiting participants.
Verified December 2013 by Octapharma
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01712438
First received: October 18, 2012
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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: Allocation: Non-Randomized
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)


Estimated Enrollment: 100
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

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712438

Contacts
Contact: Sigurd Knaub, PhD 01141 55452141 sigurd.knaub@octapharma.com

Locations
United States, California
UC Davis Recruiting
Sacramento, California, United States, 95817
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
United States, Massachusetts
Harvard Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
MSU Center for Bleeding and Clotting Disorders Recruiting
East Lansing, Michigan, United States, 48823
Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Ontario
Mc Master Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8S4K1
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Hopital Ste-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Germany
University Hospital Frankfurt/M Recruiting
Frankfurt, Germany, 60590
Universitaetsklinik Muenster Not yet recruiting
Muenster, Germany, 48149
Poland
University Medical School Warsaw Recruiting
Warsaw, Poland, 00-576
United Kingdom
Cambridge University Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Guy's and St. Thomas Hospital Recruiting
London, United Kingdom
Great Ormond Street Hospital for Children Recruiting
London, United Kingdom, WC1N3JH
Contact: Raina Liesner, MD         
Principal Investigator: Raina Liesner, MD         
Sponsors and Collaborators
Octapharma
  More Information

No publications provided

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01712438     History of Changes
Other Study ID Numbers: GENA-05, 2012-002554-23
Study First Received: October 18, 2012
Last Updated: December 23, 2013
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

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

ClinicalTrials.gov processed this record on April 17, 2014