Brief Title
Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq
Official Title
Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq - A Canadian Study
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 induction (ITI) success in severe and moderate haemophilia A patients with inhibitors
Study Type
Observational
Primary Outcome
Efficacy of Wilate or Nuwiq in achieving complete or partial immune tolerance induction (ITI) success in moderate and severe haemophilia A patients with inhibitors
Secondary Outcome
Time necessary to achieve complete or partial ITI success
Condition
Hemophilia A
Intervention
Wilate or Nuwiq
Study Arms / Comparison Groups
Wilate or Nuwiq prospective cohort
Description: Evaluable haemophilia A patients with an inhibitor against FVIII enrolled prospectively
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
80
Start Date
June 28, 2018
Completion Date
November 20, 2020
Primary Completion Date
November 20, 2020
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: 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
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Sri Adapa, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03344003
Organization ID
WIL-26
Responsible Party
Sponsor
Study Sponsor
Octapharma
Study Sponsor
Sri Adapa, Study Director, Octapharma
Verification Date
February 2021