Evaluation of NXT007 versus Emicizumab Prophylaxis in Patients with Hemophilia A

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What is this study about?

Hemophilia A is a rare condition in which the blood does not clot properly, leading to frequent bleeding episodes that can affect joints and other parts of the body. The study examines two preventive medicines: a new product called NXT007, which is a laboratory‑made antibody that helps the blood clot, and an existing treatment called Emicizumab. Both medicines are given by a small needle under the skin, known as a subcutaneous injection, and are intended to reduce the number of bleeding episodes.

The purpose of the trial is to determine whether NXT007 works at least as well as Emicizumab in preventing bleeds. Participants receive regular injections for several months and attend scheduled visits where doctors check their health, collect blood samples, and ask about daily activities and quality of life. The main way the study measures success is by counting the average number of bleeding episodes that need treatment each year, called the annualized number of treated bleeds.

Throughout the study, safety is closely watched. Researchers look for any side effects such as reactions at the injection site, allergic responses, or signs of clotting problems. Participants also complete simple questionnaires about how their condition affects everyday life, helping to assess both the medical and personal impact of the treatments.

1 enrollment and randomization

after providing informed consent, you will undergo baseline medical assessments and be assigned randomly to receive either nxt007 or emicizumab prophylaxis.

2 baseline assessments

you will have a physical examination, laboratory tests, and complete a quality of life questionnaire to establish baseline values.

3 initiation of study medication

you will receive the assigned study drug by subcutaneous injection.

the dose and injection frequency are defined by the study protocol and are not disclosed here; the medication will be administered throughout the study period.

4 month 2 visit – start of primary efficacy collection

from this visit onward, the primary endpoint, the annualized number of treated bleeds (abr), will be recorded until the clinical cutoff date.

you will continue to record any bleeds and receive study medication as scheduled.

5 regular follow‑up visits

you will attend scheduled visits (typically monthly) for safety assessments, injection training, and collection of blood samples.

blood samples will be analyzed for plasma concentration of the study drug and for the presence of anti‑drug antibodies.

adverse events, injection‑site reactions, and any signs of thrombotic complications will be evaluated at each visit.

6 month 8 visit – quality of life assessment

you will complete the quality of life questionnaire again to assess changes since baseline.

7 ongoing monitoring of safety and efficacy

throughout the trial you will be instructed to report any adverse events, including severe hypersensitivity, anaphylaxis, or thromboembolic events.

the study team will track the number of injections and dose per bleed of any additional coagulation factors or bypassing agents you may require.

8 final study visit

at the end of the study period, you will undergo final assessments, including a final quality of life questionnaire, blood sampling for drug concentration and antibody testing, and a summary of bleeding episodes.

the study medication will be discontinued after this visit.

Who Can Join the Study?

  • Have a confirmed diagnosis of severe or moderate congenital Hemophilia A (a genetic bleeding disorder) based on blood levels of factor VIII: severe means less than 1 IU/dL, moderate means 1‑5 IU/dL, and you may or may not have inhibitors (antibodies) against factor VIII.
  • Have laboratory test results for factor VIII inhibitors that were done within the past 12 months.
  • Provide medical records that show details of regular (preventive) and occasional factor VIII treatments, any use of bypassing agents (medicines that help clotting when factor VIII does not work), use of emicizumab preventive treatment, and the number and type of bleeding episodes during the last 6 months.
  • If you are currently using treatment only when bleeding occurs (on‑demand therapy), you must agree to switch to a regular preventive treatment with either emicizumab or NXT007 as assigned by the study.
  • Agree to follow the study’s contraception requirements (use birth control as instructed).
  • Be either male or female and belong to an age group allowed by the study (children, adolescents, or adults).

Who Cannot Join the Study?

  • If you have an allergy to any part of the study drug, the tests, or any ingredient, you cannot join the trial.
  • If you are currently taking medicines that change the whole immune system (systemic immunomodulators) such as interferon or rituximab, or plan to start them during the study (except medicines used to treat HIV called antiretroviral therapy), you are not eligible.
  • If you would refuse to receive plasma-derived or other blood product transfusion support in an emergency, you cannot participate.
  • If you have a planned surgery during the study period (except very minor procedures like a simple tooth extraction or a small incision to drain an infection), you are excluded.
  • If you have a history of abnormal heart rhythms in the lower chambers of the heart (ventricular dysrhythmias) or risk factors such as structural heart disease (for example, a very weak main pumping chamber called severe left ventricular systolic dysfunction or a thickened heart muscle called left ventricular hypertrophy) or coronary heart disease (narrowed heart arteries that cause chest pain or reduced blood flow, known as ischemia), you cannot join.
  • If you have an abnormal result on an ECG (a test that records the heart’s electrical activity) that is considered important—such as a complete left bundle branch block or a second- or third-degree atrioventricular heart block—or if you have had a previous myocardial infarction (heart attack), you are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Of Debrecen Debrecen Hungary
Children’s Health Ireland Dublin Ireland
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Rigshospitalet Copenhagen Denmark
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Instytut Hematologii I Transfuzjologii Warsaw Poland
Bicetre Hospital Le Kremlin-Bicetre France
Cjmdlhmsk Uqrtgrebjdmqjs Swhsakgwk Woluwe-Saint-Lambert Belgium
Hilnmapc Vbgn dkafrncc Barcelona Spain
Ajzforbuz Umq Amsterdam The Netherlands
Gceylh Udbrdzwlgu Fkfxhofoj Frankfurt Germany
Uzexqwywgyqhqp Cjvxmwz Krakbzevg Gdansk Poland
Hzmfufke Dm Lw Smtgq Clyy I Sgfb Pjk Barcelona Spain
Uwvzwaaeee Mbthfem Cgujrn Hylnbsaawkbfchznp Hamburg Germany
Uzulxgolux Dwhnd Scubn Dv Rovl Lo Sedjsxcq Rome Italy
Uckmvfdruwbn Mpdwvny Cbkhqqn Goodmgnyh Groningen The Netherlands
Fwbhsucil Phct Ll Ivjjnlubegqos Bwczrnrui Dob Hlqccpul Udwlptuvhqcng Lg Pte Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
30.06.2026
Belgium Belgium
Not yet recruiting
30.06.2026
Denmark Denmark
Not yet recruiting
30.06.2026
France France
Not yet recruiting
30.06.2026
Germany Germany
Not yet recruiting
30.06.2026
Hungary Hungary
Not yet recruiting
30.06.2026
Ireland Ireland
Not yet recruiting
30.06.2026
Italy Italy
Not yet recruiting
30.06.2026
Poland Poland
Not yet recruiting
30.06.2026
Spain Spain
Recruiting
30.06.2026
The Netherlands The Netherlands
Not yet recruiting
30.06.2026

Trial locations

Investigated drugs:

NXT007 is a laboratory‑engineered antibody that attaches to two proteins involved in blood clotting, called factor IXa and factor X. By linking these proteins, it helps the blood form clots even in people who lack the normal clotting factor needed for hemophilia A. In the trial, participants receive NXT007 as a subcutaneous injection (a shot under the skin) on a regular schedule to try to prevent bleeding episodes.

Hemlibra (emicizumab) is a medication that also works like a bridge between factor IXa and factor X, helping the blood clot more normally in people with hemophilia A. It is given as a subcutaneous injection and is used as a preventive (prophylaxis) treatment to reduce the number of bleeds. In this study, Hemlibra serves as the comparison treatment to see how well NXT007 works.

Investigated diseases:

Hemophilia A – Hemophilia A is a hereditary disorder in which the blood lacks enough clotting factor VIII. Because of this shortage, blood does not clot normally, so bleeding lasts longer after cuts or injuries. People with the condition often experience bruising, nosebleeds, and bleeding into muscles or joints. Repeated joint bleeds can cause swelling, pain, and reduced movement over time. The disorder is present from birth and may become more noticeable as a person becomes more active.

Trial ID:
2025-522435-33-00
Protocol code:
BO45887
Trial Phase:
Therapeutic confirmatory (Phase III)

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