Description:

ODM derived from http://clinicaltrials.gov/show/NCT00623727

Link:

http://clinicaltrials.gov/show/NCT00623727

Keywords:
Versions (2) ▾
  1. 12/10/13
  2. 4/15/14
Uploaded on:

April 15, 2014

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY 4.0
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Eligibility NCT00623727 Hemophilia A

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age 12 Years to 70 Years
male, male gender
Subjects with severe hemophilia A (< 1% factor VIII [FVIII]:C)
Subjects with >= 150 exposure days (EDs) with any FVIII in total
Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule
Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records
Subjects with no measurable inhibitor activity
Subjects with no history of FVIII inhibitor antibody formation
Written informed consent by subject and parent / legal representative, if < 18 years
Exclusion Criteria
Subjects who are receiving primary prophylaxis
Subjects on prophylaxis with documented requirements of > 75 IU/kg/week
Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)
Renal dysfunction
Elevated hepatic transaminases
Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study
Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG)
Subjects who require any pre-medication for FVIII injections