MedDataX Logo

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

NCT ID: NCT05936580

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hemophilia A

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nuwiq

All 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.

Group Type EXPERIMENTAL

Nuwiq

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nuwiq

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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)
2. At least 12 years of age
3. Scheduled to undergo major surgery\* requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A
4. Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations

Exclusion Criteria

1. Coagulation disorder other than haemophilia A
2. Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL)
3. 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)
4. Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
5. Pregnancy, except in participants with a planned caesarean section
6. Already had surgery in this study
7. Current participation in another interventional clinical trial
8. Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit
Minimum Eligible Age

12 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Octapharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Johannes Oldenburg

Role: PRINCIPAL_INVESTIGATOR

Experimental Haematology and Transfusion Medicine, University Clinic Bonn

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UT Health San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Helsinki University Hospital,Coagulation Disorder Unit

Helsinki, , Finland

Site Status RECRUITING

Avenue de la République

Chambray-lès-Tours, , France

Site Status RECRUITING

CHU de Nantes Hôtel-Dieu

Nantes, , France

Site Status RECRUITING

Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin

Bonn, , Germany

Site Status RECRUITING

Gerinnungszentrum Rhein-Ruhr

Duisburg, , Germany

Site Status RECRUITING

Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik

Hamburg, , Germany

Site Status RECRUITING

Aziendo Ospedaliera "Puglieze Ciaccio"

Catanzaro, , Italy

Site Status RECRUITING

Policlinico "P. Giaconne"

Palermo, , Italy

Site Status RECRUITING

Clinical Center for Serbia

Belgrade, , Serbia

Site Status RECRUITING

Hospital Universitario la Paz

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status RECRUITING

Insel Spital Bern

Bern, , Switzerland

Site Status NOT_YET_RECRUITING

St. James's University Hospital

Leeds, , United Kingdom

Site Status RECRUITING

Centro Hospitalario Pereira Rossell

Montevideo, , Uruguay

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Finland France Germany Italy Serbia Spain Switzerland United Kingdom Uruguay

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cristina Solomon

Role: CONTACT

Phone: +41795859042

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39624518 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GENA-23

Identifier Type: -

Identifier Source: org_study_id