Related Experiment Video

Updated: Jul 30, 2025

Tail Vein Transection Bleeding Model in Fully Anesthetized Hemophilia A Mice
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Tail Vein Transection Bleeding Model in Fully Anesthetized Hemophilia A Mice

Published on: September 30, 2021

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Design of a Real-World Observational Study in Previously Untreated and Minimally Treated Hemophilia A Patients:

Johannes Oldenburg1, Susan Halimeh2, Georgina W Hall3

  • 1Institute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, Bonn, Germany.

TH Open : Companion Journal to Thrombosis and Haemostasis
|May 14, 2023
PubMed

Insights

The Protect-NOW study evaluates real-world effectiveness and safety of Nuwiq, octanate, and wilate in previously untreated patients with severe hemophilia A. This research aids clinical decisions for hemophilia A treatment in routine practice.

Area of Science:

  • Hematology
  • Pharmacology
  • Clinical Research

Background:

  • Previous clinical trials assessed Octapharma's factor VIII (FVIII) products (Nuwiq, octanate, wilate) in severe hemophilia A patients.
  • Real-world data are crucial for complementing clinical trial findings and understanding treatment in routine practice.

Purpose of the Study:

  • To evaluate the real-world effectiveness, safety, and utilization of Nuwiq, octanate, and wilate.
  • To assess treatment patterns in previously untreated patients (PUPs) and minimally treated patients (MTPs) with severe hemophilia A.

Main Methods:

  • The Protect-NOW study is a prospective, observational, real-world study.
  • It involves 140 PUPs and MTPs with severe hemophilia A treated with Nuwiq or plasma-derived FVIII concentrates.
  • Patients are followed for 100 exposure days or up to 3 years.

Main Results:

  • Primary objectives include assessing bleeding episode prevention and treatment effectiveness, and overall safety, including inhibitor development.
  • Secondary objectives focus on utilization patterns and effectiveness in surgical prophylaxis.

Conclusions:

  • The Protect-NOW study will offer insights into the treatment of PUPs and MTPs in clinical practice.
  • Findings will support future clinical decision-making for managing severe hemophilia A.

Keywords:
coagulation factor VIIIhemophilia Ainhibitorspreviously untreated patientsreal-world study

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