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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01125813
First received: May 17, 2010
Last updated: March 11, 2013
Last verified: March 2013

May 17, 2010
March 11, 2013
June 2010
January 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment.
  • Efficacy of Treating Bleeding Episodes [ Time Frame: After each bleeding episode, up to 6 month ] [ Designated as safety issue: No ]

    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
Efficacy Assessment after a total of at least 50 EDs per subject at the end of the study at 6 months [ Time Frame: February 2011 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01125813 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A
Clinical Study to Investigate the Efficacy, Safety, and Immunogenicity of Human-cl rhFVIII in Previously Treated Patients With Severe Hemophilia A

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Severe Hemophilia A
Biological: recombinant Factor VIII
intravenous infusion of factor FVIII every other day.
Other Name: human-cl rhFVIII
Experimental: human cl-rhFVIII
Intervention: Biological: recombinant Factor VIII
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Male
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Bulgaria,   Germany,   United Kingdom
 
NCT01125813
GENA-08
Yes
Octapharma
Octapharma
Not Provided
Principal Investigator: Johannes Oldenburg, Prof. Universitaetsklinikum Bonn
Octapharma
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP