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Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A

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ClinicalTrials.gov Identifier: NCT01125813
Recruitment Status : Completed
First Posted : May 18, 2010
Results First Posted : April 22, 2013
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Octapharma

Study Description
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Brief Summary:
This study will determine the efficacy of human-cl rhFVIII in previously treated patients with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in surgical prophylaxis.

Condition or disease Intervention/treatment Phase
Severe Hemophilia A Biological: recombinant Factor VIII Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Study to Investigate the Efficacy, Safety, and Immunogenicity of Human-cl rhFVIII in Previously Treated Patients With Severe Hemophilia A
Study Start Date : June 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arms and Interventions
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Arm Intervention/treatment
Experimental: human cl-rhFVIII Biological: recombinant Factor VIII
intravenous infusion of factor FVIII every other day.
Other Name: human-cl rhFVIII


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months [ Time Frame: At least 50 Exposure Days and at least 6 months ]
    Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment.

  2. Efficacy of Treating Bleeding Episodes [ Time Frame: After each bleeding episode, up to 6 month ]

    At the end of a bleeding episode, efficacy was assessed as:

    • Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion
    • Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8-12 hours after an infusion requiring up to 2 infusions for complete resolution
    • Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution
    • None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution Efficacy was rated


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe hemophilia A ((FVIII:C <= 1%)
  • Male subjects >= 12 years of age
  • Previously treated with FVIII concentrate, at least 50 EDs
  • Immunocompetent (CD4+ count > 200/ul)
  • Negative for anti- HIV; if positive, viral load < 200 particles/u; or <400,000 copies/mL

Exclusion Criteria:

  • Other coagulation disorder than hemophilia A
  • Present of past FVIII inhibitor activity (.= 0.6 BU)
  • Severe liver and kidney disease
  • Receiving of scheduled to receive immuno-modulating drugs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125813


Locations
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Austria
Medizinische Universitaet Wien
Wien, Austria, 1090
Bulgaria
Haematological Hospital Joan Pavel
Sofia, Bulgaria, 1233
Germany
Werlhof Institut fuer Haemostaseologie GmbH
Hannover, Niedersachsen, Germany, 30159
Universitaetsklinikum
Bonn, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
SRH Kurpfalzkrankenhaus Heidelberg
Heidelberg, Germany, 69123
United Kingdom
Basingstoke & North Hampshire NHS Foundation Trust
Basingstoke, United Kingdom, RG24 9NA
University Hospital of Wales
Cardiff, United Kingdom
Royal Free Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Sponsors and Collaborators
Octapharma
Investigators
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Principal Investigator: Johannes Oldenburg, Prof. Universitaetsklinikum Bonn
More Information
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Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01125813    
Other Study ID Numbers: GENA-08
First Posted: May 18, 2010    Key Record Dates
Results First Posted: April 22, 2013
Last Update Posted: September 11, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
 Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants