Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-28

Study Completion Date

2020-11-20

Brief Summary

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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

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Wilate or Nuwiq prospective cohort

Evaluable haemophilia A patients with an inhibitor against FVIII enrolled prospectively

Wilate or Nuwiq

Intervention Type DRUG

Wilate or Nuwiq administered via intravenous injection

Wilate or Nuwiq retrospective cohort

Evaluable haemophilia A patients with an inhibitor against FVIII enrolled retrospectively

Wilate or Nuwiq

Intervention Type DRUG

Wilate or Nuwiq administered via intravenous injection

Interventions

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Wilate or Nuwiq

Wilate or Nuwiq administered via intravenous injection

Intervention Type DRUG

Other Intervention Names

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Wilate: Human von Willebrand factor / human coagulation factor VIII. Nuwiq: recombinant factor VIII (rhFVIII)

Eligibility Criteria

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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

Eligible Sex

MALE

Accepts Healthy Volunteers

No