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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Health checks and monitoring — no treatment given
Type of study: Observational (no treatment given)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Not specified by the sponsor
How long the study runs: Study runs about 148 months (dates as stated)
About the drug or intervention: Not specified by the sponsor
Patient visit burden: Not specified by the sponsor

In plain English

This study looks at how well three factor VIII medicines called Nuwiq, Octanate and Wilate work, and how safe they are, in people with severe haemophilia A. It includes people who have never had factor VIII treatment before, or have had fewer than 5 days of it. The study is run by Octapharma, the company that makes these medicines.

Who can take part

People of any age, any ethnic background, male or female
Severe haemophilia A (factor VIII level below 1%)
A doctor has already decided to prescribe an Octapharma factor VIII medicine before joining the study
Either never treated with factor VIII before, or had fewer than 5 days of treatment with it, with full records of past treatment
If an inhibitor (an antibody against the treatment) developed before, it must have happened while taking an Octapharma factor VIII medicine, and treatment with that same medicine must continue (with or without a medicine called emicizumab)
Written informed consent, given by the patient or their parent/legal guardian, before any study data is collected

Who may not be able to

Having a blood clotting disorder other than haemophilia A
Taking medicine that suppresses the immune system
Taking part in an interventional clinical trial during the study period
Taking part in another non-interventional Octapharma study

What taking part involves

• Treatment with one of three Octapharma factor VIII concentrates: Nuwiq, Octanate or Wilate
• Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Observing health over time
Ages: Not specified
Who: All
Number of participants: 200
Started: 2018-02-13
Last checked: 2025-11

Plain English Summary

What is this study?

• Testing a new treatment for haemophilia a
• Clinical study - 200 participants
• 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

Who can take part?

• Adults
• Diagnosed with haemophilia a

Where?

• Headington - John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust
• Birmingham - Birmingham Children's Hospital NHS Foundation Trust
• London - Great Ormond Street Hospital for Children NHS Trust, Haemophilia Centre
• Newcastle upon Tyne - Newcastle Haemophilia Comprehensive Care Centre, Royal Victoria Infirmary

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Octapharma's FVIII concentrates have been tested in clinical trials and registered for treatment of haemophilia A; however, as haemophilia A is a rare disease, the numbers of patients treated in studies so far are limited. For previously untreated patients (PUPs), who are typically young children, and for minimally treated patients (MTPs), who have been exposed to only minimal FVIII dosages, there is a general interest to increase the body of data on treatment effectiveness and safety, particularly related to inhibitor development. Also, specifically for PUPs, treatment algorithms are not standardized, e.g. with respect to utilisation, dosage, frequency or optimal start age of FVIII prophylaxis. Real world evidence derived from a non-interventional study (NIS) can describe product utilisation and demonstrate value over a product's life cycle and facilitate benefit-risk assessments. The purpose of this study is thus to evaluate product utilisation, effectiveness and safety, including inhibitor development information, in severe haemophilia A PUPs and MTPs, who have been prescribed Octapharma's FVIII concentrates.

Haemophilia A

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: Not specified
Who can join: All genders

Treatment history

Treatments you must have had:

✓ FVIII concentrates

What the study is looking for

✓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

Who cannot take part

✗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

See the full 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