Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia a Patients

Description

International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.

Conditions

Haemophilia a

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Study Overview

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Study Details

Study overview

International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.

Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia a Patients Entering Routine Clinical Treatment with Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW

Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia a Patients

Condition
Haemophilia a
Intervention / Treatment

-

Contacts and Locations

Las Vegas

Cure 4 The Kids Foundation Children's Specialty Center, Las Vegas, Nevada, United States, 89109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male and female patients of any age and ethnicity
  • * Severe haemophilia A (FVIII:C\<1%)
  • * Decision to prescribe Octapharma's FVIII concentrate before enrollment into the study
  • * Either
  • * No previous treatment with FVIII concentrates or other blood products containing FVIII (PUPs) OR
  • * Less than 5 Exposure Days (EDs) to FVIII concentrates or other blood products containing FVIII (MTPs), if
  • * data are available on all previous treatment, AND
  • * they did not develop an inhibitor at any time point, OR
  • * they developed an inhibitor during treatment with an Octapharma FVIII concentrate AND continue treatment with THIS Octapharma FVIII concentrate (in the presence or absence of emicizumab).
  • * Voluntarily given, fully informed written and signed consent obtained before any study-related data documentation is conducted (obtained from the patient's parent/legal guardian)
  • * Diagnosis with a coagulation disorder other than haemophilia A
  • * Concomitant treatment with any systemic immunosuppressive drug
  • * Participation in an interventional clinical trial during the time period evaluated
  • * Participation in another non-interventional study of Octapharma

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Octapharma,

Sigurd Knaub, PhD, STUDY_DIRECTOR, Octapharma

Study Record Dates

2030-06