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Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq (PREVAIL)

O

Octapharma

Status

Terminated

Conditions

Hemophilia A

Treatments

Drug: Wilate or Nuwiq

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Enrollment

14 patients

Sex

Male

Volunteers

No Healthy Volunteers

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

Trial design

14 participants in 2 patient groups

Wilate or Nuwiq prospective cohort
Description:
Evaluable haemophilia A patients with an inhibitor against FVIII enrolled prospectively
Treatment:
Drug: Wilate or Nuwiq
Wilate or Nuwiq retrospective cohort
Description:
Evaluable haemophilia A patients with an inhibitor against FVIII enrolled retrospectively
Treatment:
Drug: Wilate or Nuwiq

Trial documents
1

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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