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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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):

May 17, 2010
May 18, 2010
January 21, 2013
April 22, 2013
September 11, 2017
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 ]
    Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment.
  • 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
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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: Male
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Bulgaria,   Germany,   United Kingdom
 
 
NCT01125813
GENA-08
Yes
Not Provided
Not Provided
Octapharma
Octapharma
Not Provided
Principal Investigator: Johannes Oldenburg, Prof. Universitaetsklinikum Bonn
Octapharma
August 2017

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