Last updated on August 2019

Non-interventional Post-authorisation Study to Document the Immunogenicity Safety and Efficacy of NUWIQ


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hemophilia A
  • Age: - 100 Years
  • Gender: Male

Inclusion Criteria:

  • Haemophilia A (FVIII:C 2%) based on medical history; at least 100 patients should have severe haemophilia A (FVIII:C < 1%)
  • Male patients of any age
  • Previous treatment with a FVIII concentrate for more than 150 EDs
  • Availability of detailed documentation (patient diary, log book, etc.) covering either the last 50 EDs or the last 2 years per patient to confirm treatment modality (i.e., prophylaxis, on-demand, recent surgery, or immune tolerance induction)
  • Inhibitor negative (< 0.6 BU) at study entry as confirmed by a recovery test with previous FVIII product and inhibitor test in a central laboratory
  • Immunocompetence (CD4+ count > 200/L), HIV-negative, or having a viral load < 200 particles/L or < 400,000 copies/mL
  • Decision to prescribe Human-cl rhFVIII before enrolment into the study
  • Written informed consent by the patient or the patient's parent or legal guardian

Exclusion Criteria:

  • Patients treated with any investigational medicinal product (IMP) except FVIII IMP within 30 days prior to the Screening Visit or patients planning to undergo treatment with any IMP other than Human-cl rhFVIII are not eligible for enrolment into the study.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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