Actively Recruiting

Phase 4
Age: 12Years +
FEMALE
NCT05936580

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

Led by Octapharma · Updated on 2026-05-12

28

Participants Needed

16

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women or girls with haemophilia A with factor VIII activity between 1% and less than 40%, or 40%-50% with documented significant bleeding history or prior FVIII treatment
  • At least 12 years of age
  • Scheduled for major surgery requiring factor VIII treatment, including elective, emergency, or planned caesarean sections
  • Provided freely given written informed consent according to local regulations
Not Eligible

You will not qualify if you...

  • Any coagulation disorder other than haemophilia A
  • Presence or history of factor VIII inhibitors (≥0.6 Bethesda units/mL)
  • Severe liver or kidney disease (ALT or AST levels greater than 5 times normal, or creatinine over 120 µmol/L)
  • Known allergy to Nuwiq or its ingredients
  • Pregnancy unless undergoing planned caesarean section
  • Previous surgery in this study
  • Current participation in another interventional trial
  • Use of investigational medicinal products within 30 days before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

UT Health San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

2

Helsinki University Hospital,Coagulation Disorder Unit

Helsinki, Finland

Actively Recruiting

3

Avenue de la République

Chambray-lès-Tours, France

Actively Recruiting

4

CHU de Nantes Hôtel-Dieu

Nantes, France

Actively Recruiting

5

Chu de Strasbourg

Stasbourg, France

Not Yet Recruiting

6

Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin

Bonn, Germany

Actively Recruiting

7

Gerinnungszentrum Rhein-Ruhr

Duisburg, Germany

Actively Recruiting

8

Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik

Hamburg, Germany

Actively Recruiting

9

Aziendo Ospedaliera "Puglieze Ciaccio"

Catanzaro, Italy

Actively Recruiting

10

Policlinico "P. Giaconne"

Palermo, Italy

Actively Recruiting

11

Clinical Center for Serbia

Belgrade, Serbia

Actively Recruiting

12

Hospital Universitario la Paz

Madrid, Spain

Actively Recruiting

13

Hospital Universitario Virgen del Rocio

Seville, Spain

Actively Recruiting

14

Insel Spital Bern

Bern, Switzerland

Not Yet Recruiting

15

St. James's University Hospital

Leeds, United Kingdom

Actively Recruiting

16

Centro Hospitalario Pereira Rossell

Montevideo, Uruguay

Not Yet Recruiting

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Research Team

C

Cristina Solomon

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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