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Hemophilia APhase 4NCT05936580

Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

A Phase 4 study testing Nuwiq in people with Hemophilia A, run by Octapharma at 16 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery Read more about this study

Who is it for?
Ages 12 years and older, women only
Conditions the study is for
Hemophilia A
What is being tested?
Nuwiq
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
16 sitesin 10 countries
Study dates
Apr 2026to Feb 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Women/girls with haemophilia A (FVIII:C ≥1-<40%) according to medical history. Additionally, women/girls with documented FVIII activity levels between ≥ 40% and 50% may be included if there is a documented history of clinically significant bleeding episodes consistent with haemophilia A; and/or either documented prior treatment with FVIII concentrates or a clinical indication that FVIII treatment would have been appropriate (e.g., use of FVIII from a family member, or treatment with alternative haemostatic agents due to access limitations)
  • At least 12 years of age
  • Scheduled to undergo major surgery* requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A
  • Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations

Who cannot join

  • Coagulation disorder other than haemophilia A
  • Present or past FVIII inhibitor (≥0.6 Bethesda units [BU]/mL)
  • Severe liver or kidney disease (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels >5 times the upper limit of normal; or creatinine >120 μmol/L)
  • Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
  • Pregnancy, except in participants with a planned caesarean section
  • Already had surgery in this study
  • Current participation in another interventional clinical trial
  • Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit

Trial locations and contacts

16 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Cristina Solomon contact

+41795859042

cristina.solomon@octapharma.com

16 sites in 10 countries

France3 sites, 3 recruiting

  • Avenue de la République

    Chambray-lès-Tours

    Recruiting

  • CHU de Nantes Hôtel-Dieu

    Nantes

    Recruiting

  • Chu de Strasbourg

    Stasbourg

    Not yet recruiting

Other trials in France

Germany3 sites, 3 recruiting

  • Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin

    Bonn

    Recruiting

  • Gerinnungszentrum Rhein-Ruhr

    Duisburg

    Recruiting

  • Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik

    Hamburg

    Recruiting

Other trials in Germany

Italy2 sites, 2 recruiting

  • Aziendo Ospedaliera "Puglieze Ciaccio"

    Catanzaro

    Recruiting

  • Policlinico "P. Giaconne"

    Palermo

    Recruiting

Other trials in Italy

Spain2 sites, 2 recruiting

  • Hospital Universitario la Paz

    Madrid

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville

    Recruiting

Other trials in Spain

United States1 site, 1 recruiting

  • UT Health San Antonio

    San Antonio, Texas, 78229

    Recruiting

Other trials in United States

Finland1 site, 1 recruiting

  • Helsinki University Hospital,Coagulation Disorder Unit

    Helsinki

    Recruiting

Other trials in Finland

Serbia1 site, 1 recruiting

  • Clinical Center for Serbia

    Belgrade

    Recruiting

Other trials in Serbia

Switzerland1 site, 1 recruiting

  • Insel Spital Bern

    Bern

    Not yet recruiting

Other trials in Switzerland

United Kingdom1 site, 1 recruiting

  • St. James's University Hospital

    Leeds

    Recruiting

Other trials in United Kingdom

Uruguay1 site, 1 recruiting

  • Centro Hospitalario Pereira Rossell

    Montevideo

    Not yet recruiting

Other trials in Uruguay

About this study

Official title: Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery - an International, Open-label, Non-controlled Study (NuDIMENSION)

Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery

Read the detailed description

Female patients with mild to moderate haemophilia A will often need FVIII concentrates to provide haemostatic cover during major surgery. This prospective, open-label, non-controlled, single-arm, multinational, multicentre study aims to evaluate the overall perioperative haemostatic efficacy of Nuwiq in women/girls over 12 with haemophilia A undergoing major surgery requiring FVIII treatment

Conditions
Hemophilia A
Being tested
Nuwiq
Medical subject headings
Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NuwiqDrug

    Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).

Study groups in NCT05936580
Study groupRoleWhat they receive
NuwiqExperimentalAll patients receiving Nuwiq (recombinant FVIII). Nuwiq will be administered intravenously in accordance with the relevant prescribing information. Treatment will be repeated as necessary every 8-24 hours until adequate wound healing, then - if required - for at least another 7 days to maintain FVIII plasma levels of 30-60 IU/dL.
Receives: Drug: Nuwiq

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall haemostatic efficacy

    Overall haemostatic efficacy of treatment measured as binary "success" or "failure". The overall perioperative haemostatic efficacy of Nuwiq will be adjudicated by an Independent Data Monitoring Committee (IDMC) and determined using a composite assessment algorithm that considers the surgeon's assessment of intraoperative haemostatic efficacy and the investigator's assessment of postoperative haemostatic efficacy to classify the overall haemostatic efficacy as success or failure.

    Measured: During surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure

Secondary outcomes (8)

  1. Intraoperative haemostatic efficacy

    Assessment of intraoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale:

    Excellent: Intraoperative blood loss was lower than or equal to the average expected blood loss for the type of procedure performed in a patient with normal haemostasis and of the same sex, age, and stature

    Good: Intraoperative blood loss was higher than the average expected blood loss but lower or equal to the maximal expected blood loss for the type of procedure in a patient with normal haemostasis.

    Moderate: Intraoperative blood loss was higher than the maximum expected blood loss for the type of procedure performed in a patient with normal haemostasis, but haemostasis was controlled.

    None: Haemostasis was uncontrolled, necessitating a change in the clotting factor replacement regimen.

    Measured: During surgery: From first skin incision to last suture

  2. Postoperative haemostatic efficacy

    Assessment of postoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale:

    Excellent: No postoperative bleeding or oozing that was not due to complications of surgery. All postoperative bleeding (due to complications of surgery) was controlled with Nuwiq as anticipated for the type of procedure.

    Good: No postoperative bleeding or oozing that was not due to complications of surgery. Control of postoperative bleeding due to complications of surgery required increased dosing with Nuwiq or additional injections not originally anticipated for the type of procedure.

    Moderate: Some postoperative bleeding and oozing that was not due to complications of surgery. Control of postoperative bleeding required increased dosing with Nuwiq or additional injections not originally anticipated for the type of procedure.

    None: Extensive uncontrolled postoperative bleeding and oozing.

    Measured: During surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure

  3. Allogenic blood products

    Use of allogeneic blood products (red blood cells, platelets, and other blood products)

    Measured: During surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure

  4. FVIII plasma levels

    Perioperative plasma levels

    Measured: ≤30 minutes before and 15-30 minutes after Nuwiq injection

  5. Perioperative haemostatic efficacy per WFH criteria

    Assessed using 4-point scale recommended by WFH:

    Excellent: Intra- and post-operative blood loss similar to non-haemophilic patient. No extra doses of FVIII/bypassing agents needed Good: Intra- and/or post-operative blood loss slightly increased over expectation for non-haemophilic patient, but judged to be clinically insignificant. No extra doses of FVIII/bypassing agents needed Fair: Intra- and/or post-operative blood loss increased over expectation for the non-haemophilic patient, and additional treatment needed. Extra dose of FVIII/bypassing agents needed, or increased blood component of anticipated transfusion requirement Poor: Significant intra- and/or post-operative blood loss substantially increased over expectation for non-haemophilic patient, requires intervention not explained by medical issue other than haemophilia. Unexpected hypotension, unexpected transfer to ICU due to bleeding, substantially increased blood component of the anticipated transfusion requirement

    Measured: ≤30 minutes before and 15-30 minutes after Nuwiq injection

  6. Adverse events

    Incidence of adverse events recorded during the full study period

    Measured: From start of first Nuwiq injection to 30 ±3 days following the surgical procedure

  7. Thrombotic events

    Incidence of thrombotic events during the study

    Measured: From start of first Nuwiq injection to 30 ±3 days following the surgical procedure

  8. FVIII inhibitor formation

    Incidence of FVIII inhibitor formation

    Measured: From start of first Nuwiq injection to 30 ±3 days following the surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2023
  2. Study startApr 2026 (estimated)
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05936580
Sponsor's protocol ID
GENA-23
Status last verified
Jan 2026
First submitted
8 Jun 2023
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Marquardt N, Langer F, Holstein K, Alvarez Roman MT, Nunez Vazquez R, Miljic P, Drillaud N, Ardillon L, Lehtinen AE, Santoro RC, Napolitano M, Siragusa S, Gidley G, Jansen M, Knaub S, Oldenburg J. Design of an international, phase IV, open-label study of simoctocog alfa in women/girls with hemophilia A undergoing surgery (NuDIMENSION). Ther Adv Hematol. 2024 Dec 1;15:20406207241300040. doi: 10.1177/20406207241300040. eCollection 2024.

    PubMed 39624518

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nuwiq in people with Hemophilia A, run by Octapharma at 16 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France, Germany, Italy, Spain, United States and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cristina Solomon (+41795859042, cristina.solomon@octapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall haemostatic efficacy (time frame: During surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05936580, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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