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

Launched by OCTAPHARMA · Oct 3, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of three different treatments—Nuwiq, Octanate, and Wilate—for patients with severe haemophilia A who have either never received treatment or have only had limited treatment. The goal is to understand how well these treatments work in real-life situations outside of a controlled clinical setting. The trial is currently recruiting participants of all ages and genders who meet specific criteria, including having severe haemophilia A and a decision to start treatment with one of the Octapharma products before joining the study.

To be eligible, participants must either have never used any treatment containing factor VIII (a protein important for blood clotting) or have had very limited exposure (less than five treatment days) without developing complications. They will need to provide consent, which can be done by a parent or legal guardian if they are minors. Throughout the trial, participants will receive one of the treatments and be monitored for how well it works and any side effects that may occur. This study is essential in helping doctors understand the best treatment options for patients with severe haemophilia A.

Gender

ALL

Eligibility criteria

• Inclusion 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)
• Exclusion Criteria:
• • 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