Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/17/2019 |
| Start Date: | January 2015 |
| End Date: | December 2019 |
| Contact: | Sigurd Knaub, PhD |
| Email: | sigurd.knaub@octapharma.com |
| Phone: | 41 55 451 2141 |
Prospective, Multinational, Non-interventional Post-authorisation Study to Document the Long-term Immunogenicity, Safety, and Efficacy of Human-cl rhFVIII (Simoctocog Alfa) in Patients With Haemophilia A Treated in Routine Clinical Practice
Prospective, multinational, non-interventional post-authorisation study to collect additional
clinical data and to ensure consistency in the long-term between the outcome from
pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients)
and routine clinical practice. Besides aspects such as general product safety and efficacy,
there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis
of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor
testing in the laboratory.
clinical data and to ensure consistency in the long-term between the outcome from
pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients)
and routine clinical practice. Besides aspects such as general product safety and efficacy,
there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis
of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor
testing in the laboratory.
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/µL), HIV-negative, or having a viral load < 200
particles/µL 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.
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