Status:
TERMINATED
Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq
Lead Sponsor:
Octapharma
Conditions:
Hemophilia A
Eligibility:
MALE
Brief Summary
Uncontrolled, multi-centre, non-interventional study with a prospective and a retrospective cohort, to evaluate the efficacy of Wilate or Nuwiq in achieving complete or partial immune tolerance induct...
Eligibility Criteria
Inclusion
- Male patients of any age with moderate or severe haemophilia A.
- Patients with a first occurrence of inhibitors, inhibitors refractory to previous ITI attempt(s), or relapsed inhibitors to FVIII, with an inhibitor titre of ≥0.6 BU measured on 2 separate occasions at least 2 weeks apart.
- Informed written consent from the patient and/or the patient's parent(s) or legal guardian(s)
- For patients in the prospective cohort:
- Patients who are currently on Wilate or Nuwiq ITI, have just initiated ITI, or are planned to initiate ITI treatment with Wilate or Nuwiq.
- For patients in the retrospective cohort:
- Patients having received Wilate or Nuwiq ITI before entry into this study. Retrospective data will be collected for a maximum of 3 years before enrolment into the study. To be eligible, the following information is needed:
- Wilate or Nuwiq treatment details (start date, dose, treatment frequency, and dose change).
- Reliably documented bleeding frequency.
- FVIII inhibitor titres.
- FVIII half-life.
- FVIII IVR.
Exclusion
- Patients who meet any of the following criteria are not eligible for the study:
- Congenital or acquired bleeding disorders other than haemophilia A.
- A history of hypersensitivity to blood products and/or plasma-derived FVIII concentrates.
- Inability to speak/read English or French well enough to provide consent and adhere to the study.
- People who are receiving other non-factor therapies, e.g. concizumab
Key Trial Info
Start Date :
June 28 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 20 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03344003
Start Date
June 28 2018
End Date
November 20 2020
Last Update
August 9 2024
Active Locations (3)
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1
Stollery children's hospital, University of Alberta
Edmonton, Alberta, Canada
2
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
3
Hamilton Health Science center
Toronto, Ontario, Canada